Category Archives: EMEA

PDA/EMA 2011 Conference

Posted on May 14, 2011 by admin| Leave a comment

PDA/EMA 2011 Conference

Full Text Here

03/05/2011 - 05/05/2011

The Parenteral Drug Association (PDA) and the European Medicines Agency are organising the 2011 PDA/EMA Conference in London, the fourth in this series. For 2011, the agenda is being broadened beyond good manufacturing practice (GMP) to include a full range of quality issues relating to pharmaceutical development, production and quality management. The three plenary sessions in the mornings of the conference days will address themes of interest to all segments of the pharmaceutical world.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA-EFPIA Information Day 2011

Posted on May 11, 2011 by admin| Leave a comment

EMA-EFPIA Information Day 2011

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23/05/2011 - 23/05/2011

The European Medicines Agency is hosting a one-day information meeting with the European Federation of Pharmaceutical Industries and Associations (EFPIA). The Info Day covers a range of topics relevant to the Paediatric Regulation including the results of a large EFPIA survey in relation to the implementation of major provisions of the Paediatric Regulation and the interpretation of the legislation and operational aspects.

For Assistance with Pediatric Development Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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Drug Regulator, EMEA, Publishes New Visual Identity, web/email addresses and organisation chart for the European Medicines Agency

Posted on December 24, 2009 by admin| Leave a comment

Drug Regulator, EMEA, Publishes New Visual Identity, web/email addresses and organisation chart for the European Medicines Agency

Full Press Release Here

This communication is intended to inform all interested parties about several important changes the European Medicines Agency will be introducing shortly

New visual identity

On 8 December 2009, The EMEA will officially launch our new visual identity, comprising a new logo, new colour chart, new typography and rebranded materials based on these elements. The EMEA are giving you advance notice of this so that you are not surprised when you start to see new documents and other materials emerging from the Agency that do not bear the familiar ‘EMEA’ logo. The EMEA have created the new visual identity as part of a wider effort to improve the quality and consistency of our communications with partners, stakeholders and the public. The main benefit is that our communications materials will now be based on professionally designed templates, and have a more harmonised look and feel than our current materials. The cornerstone of their new identity is a new logo they have created that reflects more accurately the nature and character of the Agency, which has evolved significantly in the 15 years since it, and the original logo, were created. Please visit there public website on 8 December for further details about our new visual identity and materials.

Still the European Medicines Agency, but no longer ‘the EMEA’ – and not ‘the EMA’
either

While you may be familiar with us as ‘the EMEA’, many of their partners and stakeholders over the years have told tjhem they find the acronym confusing, firstly because it does not accurately reflect their name (“What does the second ‘e’ stand for?”) and secondly because it is an acronym widely used in the business community to mean ‘Europe, Middle East and Africa’, which can cause some confusion. Since it is important to them that they communicate clear and unambiguous messages about who they are, they have decided that they will no longer be using the EMEA acronym in their communications, and it does not feature in there new logo. Please note that they will not be calling ourselves ‘the EMA’ either. Although this may seem a more obvious acronym, it is not one that feels right for them yet. They may reconsider our position at a later stage, if ‘EMA’ evolves naturally into a commonly accepted and widely used shorthand for our organisation. Until then, however, they will be using only their full name (or ‘the Agency’, for short) in our communications. (For technical reasons, they need to use some kind of abbreviation in our document references and our website and e-mail addresses. They will exceptionally use ‘EMA’ in these defined cases.)

New ‘ema.europa.eu’ address for their website and e-mails

On 8 December 2009, all Agency website and e-mail addresses will change from ‘emea.europa.eu’ to ‘ema.europa.eu’, as a consequence of there decision to discontinue our use of the acronym ‘EMEA’. From that date onwards, the address of our public website will be www.ema.europa.eu and our e-mail addresses will take the form name.surname@ema.europa.eu Please update your website bookmarks, address books, contacts databases and other resources accordingly.

New organisation chart

Over the past three months, they have been implementing a series of changes to our internal organisation, aimed at improving the functioning of the Agency and the way in which they deliver their core tasks. The new structure and allocation of responsibilities will be made public on 8 December 2009. Key changes relate to the two units responsible for medicines for human use that have been re-formed and re-named to become ‘Human Medicines Development and Evaluation’ (formerly ‘Pre-authorisation Unit’) and ‘Patient Health Protection’ (formerly ‘Post-authorisation Unit’). Staff members dealing with veterinary medicines have been re-grouped in one single sector responsible for all areas of veterinary medicines. In addition, a single sector has also been formed to manage product data and documentation related to applications for both human and veterinary medicines. Overall, the changes to our organisational structure will ensure more accountability at various management levels, and will allow them to achieve greater efficiency and effectiveness in our core activities. Further information is available in a press release published on 5 October 2009.

New public website (in early 2010)

A further, major initiative they are undertaking as part of our efforts to improve our communications is to completely redesign there public website (currently at  www.emea.europa.eu). Scheduled for launch in early 2010, their new website will offer much-improved navigation and search functionality, and content will be structured more logically and intuitively. It will also be compliant with their new visual identity. In designing the new website, they have carefully considered the feedback they have received from you, their partners and stakeholders, through surveys and other channels over the past two years. Thanks to your input, they are confident that their  redesigned website will overcome many of the weaknesses identified with the current site, and will offer a greatly improved user-experience for all Agency audiences.
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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EMEA Publishes Comments Received on Development of Guidance for Products for Treating Smoking

Posted on December 13, 2009 by admin| Leave a comment

EMEA Publishes Comments Received on Development of Guidance for Products for Treating Smoking

full text here

Interested party (Organisations or individuals) that commented on the draft Guideline as released for consultation

Stakeholder No.                Name of Organisation or individual
1 Society for Research on Nicotine and Tobacco (SRNT)
2 Royal College of Physicians
3 Smoking Prevention Group of the Spanish Respiratory Society (SEPAR)
4 National Association of Women Pharmacists (UK)
5 EFPIA
6 Merck Sharp & Dohme (Europe) Inc.
7 Johnson & Johnson Consumer Group (JJCG)
8 Dr. Peter Hajek

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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EMEA Publishes Draft Guidance on the Development of Medical Products for Insomnia

Posted on December 11, 2009 by admin| Leave a comment

EMEA Publishes Draft Guidance on the Development of Medical Products for Insomnia

Full Guidance Here

The present document should be considered as general guidance on the development for medicinal products for the treatment of acute and chronic forms of insomnia. Its main focus is on primary insomnia, however, some issues on secondary or comorbid insomnia will be mentioned as well. This document should be read in conjunction with other relevant EMEA and ICH guidelines. Based on efficacy and safety data several drugs have been approved for short-term treatment of insomnia (e.g. benzodiazepines, benzodiazepine-like products, melatonin). Recent progress in basic science and current medical practice has fostered new interest in more efficacious treatment options for the short-term treatment and particularly for long-term treatment of insomnia. For regulatory purposes this requires a different approach, particularly with regard to long-term studies (patient population, study duration, choice of endpoints, risk of tolerance and dependence, etc.). Depending on the sleep disturbance (e.g. sleep onset latency or number of awakenings) studied, distinct assessment tools for clinical and neurophysiological assessments should be used, refined or newly developed. The typical design to demonstrate efficacy is a randomized, double-blind, placebo controlled, parallel group study comparing change in the primary endpoint. The results must be robust and clinically meaningful. If an indication for long-term treatment of chronic insomnia is sought, the absence of tolerance, abuse and dependency potential should be  established in addition to long-term efficacy and safety. Taking into consideration that insomnia has considerable impact on cognitive, affective and physical domains, an efficacious treatment should not be limited to improvement of all or some aspects of sleep parameters, but also produce clinically relevant improvement in daytime functioning and quality of life.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 EMEA Publishes Draft Guidance on the Development of Medical Products for Insomnia

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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EMEA – SME Scheme Reminder

Posted on December 10, 2009 by admin| Leave a comment

EMEA – SME Scheme Reminder

Guide Here

This guide has been prepared for micro, small and medium-sized enterprises (SMEs) operating in the pharmaceutical sector. Its aim is to facilitate understanding of the main aspects of medicinal product legislation. The guide is structured to follow the chronological stages of developing a medicinal product. An overview of the scientific data requirements for obtaining a marketing authorisation in the European Union (EU) is provided. The regulatory procedures in place to optimise development and obtain an EU marketing authorisation are also summarised.

The guide focuses primarily on the requirements for authorising innovative medicinal products for human or veterinary use. The guide is not intended to be an exhaustive document but rather to raise SMEs’ awareness of the various more detailed sources of information available, with links throughout the text to additional information.

In December 2005, Commission Regulation (EC) No 2049/20051 introduced provisions aimed at promoting innovation and the development of new medicinal products for human and veterinary use by SMEs. This guide is intended to fulfil the obligation laid down in Article 12 of that Regulation, which calls for a ‘User Guide’ on the administrative and procedural aspects of medicines legislation that are of particular relevance to smaller companies to be published by the European Medicines Agency (EMEA).

Pursuant to the SME regulation, companies can access financial assistance (in the form of fee reductions and fee deferrals) and administrative assistance from the agency, details of which are outlined in Section 2 of this guide. To facilitate contact with the agency, an ‘SME Office’ was launched in December 2005 and is dedicated to addressing the particular needs of smaller companies.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 EMEA SME Scheme Reminder

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European Directive on Transitional Qualified Persons for Herbal Medicines

Posted on December 6, 2009 by admin| Leave a comment

European Directive on Transitional Qualified Persons for Herbal Medicines

The draft Directive on Traditional Herbal Medicinal Products (THMPD) widens the scope of existing EC legislation to bring certain herbal medicines under Directive
2001/83/EC1 (http://pharmacos.eudra.org/F2/eudralex/vol-1/home.htm). Specifically Article 16(g)1 of the THMPD applies Articles 49-52, of Directive 2001/83/EC to the activities of manufacture and importation (from a third country) to certain herbal medicines. Any company that manufactures and/or imports, or intends to manufacture
and/or import certain herbal medicines will require either a manufacturers licence or wholesale dealers import licence respectively, authorising such activities, that names
a Qualified Person (QP)

A QP has a personal responsibility for ensuring that the required tests and controls are carried out and must sign or certify, for each batch, that the appropriate tests have been carried out and that it complies with the relevant marketing authorisation, product licence or herbal registration and has been manufactured in accordance with Good
Manufacturing Practice. The QP must ensure that the register or record is regularly maintained and that entries are made as soon as practicable after each batch has been
manufactured and before the batch is released for sale.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 European Directive on Transitional Qualified Persons for Herbal Medicines

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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Drug Regulator, EMEA, Publishes ICH Guidance on the use of Oncolytic Viruses

Posted on November 21, 2009 by admin| Leave a comment

Drug Regulator, EMEA, Publishes ICH Guidance on the use of Oncolytic Viruses

Full Text Here

Oncolytic viruses (OV) were first observed in early clinical studies in patients with malignancies where tumour regressions were observed to coincide with viral infections or with live virus vaccinations. Since these early reports, studies using OV have progressed from anecdotal and controlled infections to specifically selecting or genetically modifying viruses for cancer treatment. OV are intended to replicate selectively in tumour tissue and spread, destroying the tissue without causing excessive damage to normal tissues.
OV can be wild type or naturally attenuated strains of viruses that possess an inherent property of selective replication and lysis of cancer cells. Additionally, viruses can be genetically modified to selectively replicate and lyse cancer cells. These modifications can include 1) the mutation of the viral coding genes that are critical for viral replication in normal cells, 2) the control of early gene expression by using tumour-specific promoters, 3) a change in the viral tissue tropism and/or cell entry process, and 4) the incorporation of transgenes into the viral genome. Examples of OV include adenovirus, measles virus, vesicular stomatitis virus (VSV), reovirus, Newcastle disease virus, herpes simplex (HSV), poxvirus, Sendai virus, and others.
Regulatory authorities represented at the ICH agree that the therapeutic potential of OV will need to be balanced against the risks associated with the use of virus that is replication competent. This document identifies general principles for the clinical development of OV.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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ida consultants freestrategyconsultation 515x64 Drug Regulator, EMEA, Publishes ICH Guidance on the use of Oncolytic Viruses

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Drug Regulators, EMEA, Re-Publish Guidance on Special Populations Geriatrics

Posted on November 20, 2009 by admin| Leave a comment

Drug Regulators, EMEA, Re-Publish Guidance on Special Populations Geriatrics

Full Text Here

It is important to ensure that clinical testing programs are carried out according to harmonised guidelines based on agreed ethical and scientific principles so that the international development of valuable innovative drugs is achieved with maximum efficiency. Harmonisation in relation to medicines for geriatric populations is an important issue because the total population of the elderly will increase significantly in the coming years in Europe, Japan and the USA. The use of drugs in this population requires special consideration due to the frequent occurrence of underlying diseases, concomitant drug therapy and the consequent risk of drug interaction.

This guideline is directed principally toward new Molecular Entities that are likely to have significant use in the elderly, either because the disease intended to be treated is
characteristically a disease of aging ( e.g., Alzheimer’s disease) or because the population to be treated is known to include substantial numbers of geriatric patients (e.g., hypertension). The guideline applies also to new formulations and new combinations of established medicinal products when there is specific reason to expect that conditions common in the elderly (e.g., renal or hepatic impairment, impaired cardiac function, concomitant illnesses or concomitant medications) are likely to be encountered and are not already dealt with in current labelling. It likewise applies when the new formulation or new combination is likely to alter the geriatric patient’s response (with regard to either safety/ tolerability or efficacy) compared with that of the non-geriatric patient in a way different from previous formulations. The guideline also applies to new uses that have significant potential applicability to the elderly.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Drug Regulators Publish Concept Paper on the Need to Revise Clinical Guidance for Depression

Posted on November 11, 2009 by admin| Leave a comment

Drug Regulators,EMEA, Publish Concept Paper on the Need to Revise Clinical Guidance for Depression

Full text Hear

Major Depressive Disorder (MDD) is one of the most common psychiatric disorders, which is the fourth leading cause of global disease burden and affects about 15 % of the general population. As outlined in the guidance document MDD is not a benign disorder and risk of suicide is considerable. Although a broad therapeutic armamentarium for treatment of major depressive episodes (MDE) is available, still about one-third of patients treated for the condition do not respond satisfactorily to the first antidepressant described. Incomplete treatment response or treatment resistance have been described commonly in up to 30 % of the treated patient population, and may even as high as 60 % if treatment resistant depression (TRD) is defined as absence of remission. However, whereas the clinical picture of TRD is common in everyday practice, the conceptual elaboration and definition of clear criteria for incomplete response and TRD has been limited. In a clinical pragmatic view a patient is considered suffering from TRD when consecutive treatment with two products of different pharmacological classes, used for a sufficient length of time at an adequate dose, fail to induce an acceptable effect. As no specific treatments have been approved for this condition and scientific data base is limited, TRD is mentioned in the guideline on treatment of depression, however, no specific guidance has been given (CPMP/EWP/518/97 rev.1). Recently new diagnostic criteria for TRD including operationalizing severity of resistance have been suggested and in scientific advice procedures possible study designs have been proposed.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Drug Regulators EMEA publish Draft Guidance on the Use of Near Infrared Spectroscopy

Posted on November 10, 2009 by admin| Leave a comment

Drug Regulators EMEA publish Draft Guidance on the Use of Near Infrared Spectroscopy

Full text Hear

Near Infrared Spectroscopy (NIRS) has become a well established technique and has been used for several years in the pharmaceutical industry. The technique is useful for the identification and assay of pharmaceutical starting materials, intermediates and finished products, as well as for in-process control and monitoring purposes. NIRS constitutes one of the major methods in Process Analytical Technologies (PAT). This guideline provides guidance on the development, calibration, validation and maintenance of NIRS methods and the data to be submitted to the competent authorities when NIRS is the subject or part of a marketing authorisation application.
This guideline also clarifies and differentiates the data requirements for the marketing authorisation dossier and those for GMP, including change control.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Drug Regulator Publishes Core SPC for Pandemic Influenza Vaccines

Posted on October 22, 2009 by admin| Leave a comment

Drug EMEA Regulator Publishes Core SPC for Pandemic Influenza Vaccines

Two guidelines have been developed by the Vaccine Working Party (VWP) on Pandemic
Influenza vaccines:
- Guideline on dossier structure and content for marketing authorisations for pandemic
influenza vaccines (EMEA/CPMP/VEG/4717/03 Rev-1);
- Guideline on submission of marketing authorisation applications for pandemic
influenza vaccines through the centralised procedure (EMEA/CPMP/VEG/4986/03).
This harmonised SPC has been developed by the VWP in order to facilitate the submission of
the core pandemic dossier and subsequent approval of the pandemic variation: the SPC, based
upon this harmonised SPC proposal, labels and package leaflet approved in the core pandemic
dossier authorisation will normally not have to change (except for some information on the
pandemic strain) when the pandemic variation is submitted. It is intended solely for
inactivated pandemic virus derived vaccines. Please note that the text proposal should be
considered as a minimum requirement. Additional claims should be substantiated with data.
It should be read in conjunction with the following additional guidance documents:
- Guideline on Summary of Product Characteristics, published by the European
Commission
- Guideline on Pharmaceutical aspects of the product information for human vaccines
(EMEA/CPMP/BWP/2758/02)
- QRD Product Information Template with explanatory notes
- Convention to be followed for QRD Templates

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Parallel Scientific Advice at the Regualtors

Posted on October 19, 2009 by admin| Leave a comment

FDA and EMEA have a Parallel Scientific Advice Procedure – Reminder

Just a reminder that the FDA CBER (centre for biological evaluation and research) and EMEA have a combined scientific advice procedure. It is a pilot programme at the moment and is developed to offer a parallel process to industry.

On September 17, 2004, the EMEA and the FDA agreed to undertake a pilot program to provide parallel scientific advice (PSA). The pilot began on January 1, 2005 and was extended per agreement of both parties on March 13, 2006. For the FDA, this program aligns most closely to pre-IND/end of Phase II meetings. During this pilot, PSA efforts should focus primarily on important breakthrough products. The expected advantages from such interactions are.

  • increased dialogue between the two agencies and sponsors from the beginning of the lifecycle of a new product,
  • a deeper understanding of the bases of scientific advice, and
  • the opportunity to optimize product development and avoid unnecessary testing replication or unnecessary diverse testing methodologies.

These meetings are conducted under the auspices of the confidentiality arrangement between the European Commission, the EMEA, and FDA. The complete text of the agreed upon general principles for the pilot can be found at the General Principles EMEA – FDA Parallel Scientific Advice Meetings Pilot Program website.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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European Medicines Agency implements internal reorganisation

Posted on October 16, 2009 by admin| Leave a comment

PRESS RELEASE
European Medicines Agency implements internal reorganisation

The European Medicines Agency has begun implementing a series of changes to its internal  organisation aimed at improving the functioning of the Agency and the way in which it delivers its  core tasks. The changes will be introduced gradually from September to December 2009.  In line with its increased responsibilities, the Agency has developed over the past years in terms of  staff numbers and internal processes. The number of scientific committees and the complexity of  procedures have also grown, and the cross-relationship between committees brings with it the need for enhanced coordination. In addition, future legislative proposals are expected to bring further responsibilities to the Agency.
Following an Agency-wide process improvement exercise initiated in 2006, from May 2007 attention focused specifically on core business – examining processes within the two units dealing with medicinal products for human use and monitoring their interactions in order to assess their potential for adapting to future needs.

  • The resulting reorganisation includes the following key changes:
  • The life-cycle management of medicines for human use is brought together into one Unit, HumanMedicines Development and Evaluation, led by Patrick Le Courtois and responsible for the provision of advice during R&D, through to management of the review process and changes to products after they have been approved
    The creation of a Unit, Patient Health Protection, led by Noël Wathion, contributing to patient  health protection from the multiple perspectives of pharmacovigilance, risk and crisis
    management, patient and health care professional information, inspections (for both human and veterinary products), and appropriate regulatory compliance. The Unit will also be in charge of  community procedures for both centrally and non-centrally authorised products
  • Within the Unit for Veterinary Medicines and Product Data Management, led by David Mackay:
  • creation of a single Sector responsible for all areas of veterinary medicines – development, evaluation and maintenance of veterinary medicines, public and animal health (including
    safety) and veterinary regulatory affairs
  • creation of a single Sector for the management of product data and documentation related to applications for the whole Agency; it will also be involved in the development of IT systems to support scientific business processes
    Rationalisation of services within the Unit for Information and Communications Technology, led by Hans-Georg Wagner and within the Administration Unit, led by Andreas Pott

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Drug Regulators Publish Concept Paper on CJD in Plasma-Derived and Urine-Derived Medical Products

Posted on September 30, 2009 by admin| Leave a comment

EMEA publishes a concept paper on the need for a position statement on CJD and Plasma-Derived and Urine-Derived Medical Products.

CONCEPT PAPER ON THE NEED TO UPDATE THE CHMP POSITION STATEMENT ON CJD AND PLASMA-DERIVED AND URINE-DERIVED MEDICINAL PRODUCTS
(EMEA/CPMP/BWP/2879/02 REV. 1)

The last revision of the “CHMP position statement on CJD and plasma-derived and urine-derived medicinal products” (EMEA/CHMP/BWP/2879/02/rev.1) was published in June 2004.
The document is the current EMEA/CHMP guidance on CJD and vCJD and plasma-derived and urine-derived medicinal products. It includes recommendations for these products based on the knowledge on CJD and vCJD epidemiology, human tissue distribution of infectivity/abnormal prion protein and infectivity in blood.

The current position statement dates from 2004. Additional information has been accrued in this field since 2004 including the finding of four cases of vCJD infection associated with blood transfusion of non-leucodepleted red blood cells.1,2 TSE infectivity has also been detected in urine in some animal models3,4,5,6 in the clinical phase of the disease.
The CHMP opinion and recommendations reflected in the position statement were based on the knowledge on CJD and vCJD at the time of publishing. The progress in the field during the subsequent years reinforces the need to update the content of the document and to review the recommendations for these products.
The current position statement covers plasma-derived medicinal products and urine-derived medicinal products. Currently, there is no specific guidance on CJD and vCJD and advanced therapy medicinal products based on human tissues.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Drug Regulators Publish Concept Paper on Clinical Investigation of Specific Immunoglobulins

Posted on September 29, 2009 by admin| Leave a comment

EMEA Publishes Concept Paper on The Need for Guidance on the Clinical Investigation of Specific Immunoglobulins

Full Paper Here.

Both guidelines on the core SmPC for human plasma-derived hepatitis B immunoglobulin, i.e. for intramuscular use (CPMP/BPWG/4222/02) and for intravenous use (CPMP/BPWG/4027/02), have been in operation since November 2006. Other specific guidelines on core SmPC, i.e. Core SmPC for human rabies immunoglobulin for intramuscular use (CPMP/BPWG/3728/02), Core SmPC for human tetanus immunoglobulin for intramuscular use (CPMP/BPWG/3730/02) and Core SPC for human varicella immunoglobulin for intramuscular use (CPMP/BPWG/3726/02) have been in operation since February 2006. Nevertheless, no guideline on the clinical investigation of these human specific immunoglobulins is currently available. As the regulatory experience from the marketing authorisation applications, especially for human plasma-derived hepatitis B immunoglobulin has been developing during the past decades, the development of a guideline appears appropriate.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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