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This guideline describes approaches to developing process and drug substance understanding and also provides guidance on what information should be provided in CTD sections 3.2.S.2.2 – 3.2.S.2.6. It provides further clarification on the principles and concepts described in ICH guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality Systems (Q10) as they pertain to the development and manufacture of drug substance.

A company can choose to follow different approaches in developing a drug substance. For the purpose of this guideline, the terms “traditional” and “enhanced” are used to differentiate two possible approaches. In a traditional approach, set points and operating ranges for process parameters are defined and the drug substance control strategy is typically based on demonstration of process reproducibility and testing to meet established acceptance criteria. In an enhanced approach, risk management and more extensive scientific knowledge are used to select process parameters and unit operations that impact critical quality attributes (CQAs) for evaluation in further studies to establish any design space(s) and control strategies applicable over the lifecycle of the drug substance. As discussed in ICH Q8 for drug product, a greater understanding of the drug substance and its manufacturing process can create the basis for more flexible regulatory approaches. The degree of regulatory flexibility is generally predicated on the level of relevant scientific knowledge provided in the application for marketing authorisation.

Traditional and enhanced approaches are not mutually exclusive. A company can use either a traditional approach or an enhanced approach to drug substance development, or a combination of both.

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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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“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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The Medical Devices Regulations 2002 (SI No 618), as amended by the Medical Devices (Amendment) Regulations 2008, came into force on 13 June 2002 and implement the provisions of the Medical Devices Directive 93/42/EEC (as amended by Directive 2007/47/EC), the Active Implantable Medical Devices Directive 90/385/EEC (as amended by Directive 2007/47/EC) and the In Vitro Diagnostic Medical Devices Directive 98/79/EEC. These Regulations establish systems under which a manufacturer must submit to the UK Competent Authority, information about clinical investigations of medical devices to be carried out in the UK.

These Notes outline the legal requirements relating to the conduct and performance of a clinical investigation as set out in these Regulations. They also provide background and guidance to manufacturers on how to apply for pre-clinical assessment of a proposed clinical investigation in human subjects, involving a device falling within the scope of the Regulations.

Manufacturers wishing to make an application for pre-clinical assessment of a proposed clinical investigation of an active implantable medical device or a medical device to be carried out in part or in whole in the UK should apply to the Medicines & Healthcare products Regulatory Agency of the Department of Health (referred to in this document as the UK Competent Authority), in accordance with these Guidance Notes.

This guidance is intended as a general explanation of the legislation and should not be regarded as an authoritative statement of the law nor as having any legal consequence. It follows that manufacturers and others should not rely solely on this guidance but should consult the legislation referred to and make their own decisions on matters affecting them in conjunction with their lawyers and other professional advisers. The MHRA does not accept liability for any errors, omissions or other statements in the
guidance whether negligent or otherwise. An authoritative statement could be given only by the courts. Information and assistance in individual cases may be sought from the UK Competent Authority whose address and telephone number are given on pages 12 – 13 of this document.

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.”

Full text is an excell spreadsheet, its available from me on request. damien.bove@idaconsultants.com or on the EMEA website.

This question and answer document is a summary of questions reviewed by the eCTD Implementation Working Group (IWG) on the eCTD Specification.  The questions answered here relate to common questions that relate to the eCTD in all three ICH regions.  Many of the questions received on the Step 2 specification were addressed in Step 4 and do not appear in the list.   Questions concerning the timeframe for implementation of region-specific application types, module 1 implementation, lifecycle management and those questions that relate to items in the specification that direct the reader to each region are answered in guidance documents published for each region.

Questions related to the table of contents for the Common Technical Document (CTD) should be directed to the CTD question and answer section of the ICH Website.

Some of the questions posed so far address change requests to the eCTD Specification.  The change request section of this document addresses all those items received by the eCTD IWG and indicates their status.

This document will be updated as the specification undergoes change control or as new questions are submitted to the eCTD IWG.

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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The Q8 parent guidance describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format.
The Pharmaceutical Development section provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management (for definition, see ICH Q9 Quality Risk Management) to the development of a product and its manufacturing process. It is first produced for the original marketing application and can be updated to support new knowledge gained over the lifecycle4 of a product. The Pharmaceutical Development section is intended to provide a comprehensive understanding of the product and manufacturing process for reviewers and inspectors. The guidance also indicates areas where the demonstration of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. The degree of regulatory flexibility is predicated on the level of relevant scientific knowledge provided.

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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In its Communication of 10 December 2008 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on “Safe, Innovative and Accessible Medicines: a Renewed Vision for the Pharmaceutical Sector”, the Commission announced that an assessment would be made of the
application of Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (“Clinical Trials
Directive”).

This assessment would consider, in particular, various options for further improving the functioning of the Clinical Trials Directive with a view to remedy shortcomings and unintended negative consequences while taking the global dimension of clinical trials into account.

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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The European Commission has published draft guidance for comment on “Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial” Contributions should be sent by e-mail to entr-pharmaceuticals@ec.europa.eu on 8 September 2009 at the latest.

Scope

The scope of this guideline is the scope of Directive 2001/20/EC. Directive 2001/20/EC applies to all interventional clinical trials involving medicinal products as defined in Article 1(2) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (hereinafter “Directive 2001/83/EC”). This includes interventional clinical trials involving:

• Advanced Therapy Medical Products as defined in Article 2(1)(a) of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004
• Medicinal products derived from human blood or human plasma
• Immunological medicinal products as defined in Article 1(4) of Directive 2001/83/EC
• Herbal medicinal products as defined in Article 1(3) of Directive 2001/83/EC
• Radiopharmaceuticals as defined in Article 1(6) of Directive 2001/83/EC;
• Homeopathic medicinal products as defined in Article 1(5) of Directive 2001/83/EC
• Directive 2001/20/EC also applies to medicinal products for paediatric population.

The Guidance is too large to give a detailed review here but I will try and pull out the most interesting sections.

Requests for clinical trials authorisation

Covering Letter

The applicant should submit and sign a covering letter with the application. Its heading should contain the EudraCT number and the sponsor protocol number with a title of the trial. In the covering letter, the applicant should draw attention to peculiarities of the trial.

Before submitting an application to the national competent authority, the sponsor should obtain a unique EudraCT number from the EudraCT database by the procedure described in the Detailed guidance on the European clinical trials database.

Application Form

The application form is accessible via the internet by the procedure described in the Detailed guidance on the European clinical trials database. The  application form should uniquely identify the clinical trial and the organisations and key individuals responsible for the conduct of the trial.

Protocol

According to Article 2(h), 1st period, of Directive 2001/20/EC, the protocol is “a document that describes the objective(s), design, methodology, statistical
considerations and organisations of a trial.”

The content and format of the protocol should comply with Section 6 of the Community guideline on Good Clinical Practice (CPMP/ICH/135/95).

Investigators Brochure

According to Article 2(g) of Directive 2001/20/EC, the investigator’s brochure (“IB”) is “a compilation of the clinical and non-clinical data on the investigational medicinal product or products which are relevant to the study of the product or products in human subjects.” A request for authorisation has to be accompanied with an IB.

The content, format and procedures for updating the IB has to comply with Article 8(1) of the Commission Directive 2005/28/EC laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (hereinafter referred to as Directive 20005/28/EC) and with the Community guideline on Good Clinical Practice (CPMP/ICH/135/95).

Investigational Medicinal Product Dossier (IMPD)

Article 2(d) of Directive 2001/20/EC defines an IMP as follows: “[A] pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form.”

The IMP Dossier (“IMPD”) gives information to justify the quality of any IMP (i.e. including reference product and placebo) to be used in the clinical trial. It should also provide data from non-clinical studies and the previous clinical use of the IMP or justify in the application why information is not provided.

The sponsor has the possibility to submit a simplified IMPD if the information can be made available by referring to other submissions.

Non-Investigational Medicinal Products used in the Trial

Medicinal products used in the context of a clinical trial and not falling within the definition of IMP are non-investigational medicinal products (“NIMPs”). The “borderline” between IMPs and NIMPs is described in the Guidance on Investigational Medicinal Products (IMPs) and other medicinal products used in Clinical Trials. It is strongly recommended that NIMPs with marketing authorisation in the Member State concerned are used for these purposes when possible. When this is not possible, the next choice should be NIMPs with marketing authorisation in another Member State. A SmPC for each NIMP with a marketing authorisation should be submitted with the clinical trials application dossier.

Notification of Amendments

Notification/submission for information40 is only obligatory if the amendment is substantial or otherwise significant. Directive 2001/20/EC does not require notification of non-substantial amendments.

Declaration of the End of a Clinical Trial

Article 10 (c) of Directive 2001/20/EC reads as follows: “Within 90 days of the end of a clinical trial the sponsor shall notify the competent authorities of the Member State or Member States concerned and the Ethics Committee that the clinical trial has ended. If the trial has to be terminated early, this period shall be reduced to 15 days and the reasons clearly explained.”

“End of the trial” is not defined in Directive 2001/20/EC. The definition of the end of the trial should be provided in the protocol and any change to this definition for whatever reason should be notified as a substantial amendment. In most cases it will be the date of the last visit of the last patient undergoing the trial. Any exceptions to this should be justified in the protocol.

Procedure for declaring the end of the trial

The sponsor should make an end of trial declaration using the form published in Volume 10 of Eudralex – the Rules Governing Medicinal Products in the European Union

Clinical Trial Summary Report

The clinical trial summary report is part of the end of trials notification. However, the clinical trial summary report can be submitted subsequently to the end of trials notification.

Follow up

If a new event occurs after the termination of the trial that is likely to change the risk/benefit analysis of the trial and could still have an impact on the trial participants, the sponsor should notify the national competent authority and Ethics Committee of the Member State concerned and provide a proposed course of action.

Details of the Table of Contents of the Common Technical Document (CTD, eCTD) are given in the appendix.

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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The impact of the clinical trials directive on clinical drug development has been evaluated by ICREL (Impact of Clinical Research of European Legislation) who have just published their report (HEALTH-F1-2007-201002).  When the clinical trials directive was brought in in 2001, its main objectives were:

• Protection of human subjects in clinical research
• Implementation of the Good Clinical Practice (GCP) standard in all clinical trials with medicinal products
• Harmonised procedures for clinical trials authorisation from competent authorities and ethics committees
• Central collection of information on clinical trials activities and safety results

Implementation of the directive into national legislation of all 27 EU member states was completed in 2006. Principles like Clinical Trial Authorisation by the competent authority and favourable opinion of a single ethics committee within defined maximum time-lines led to significant harmonisation of the clinical trial approval process. However, differences in interpretation of the modalities for this and other processes harmonised by the CTD, led to even higher complexity levels – especially in the performance of multi-national clinical trials. Today, a sponsor of a clinical trial needs to have very detailed knowledge about every country’s national requirements for clinical trial authorisations from competent authorities and ethics committees and has to integrate the different requirements to the protocol and IMPD resulting from parallel submission in multi-national trials.

This FP7-funded ICREL project aimed at objectively measuring the impact of the clinical trials legislation on the key stakeholder groups “commercial and non-commercial
sponsors”, “competent authorities” and “ethics committees” in the European Union by providing:

• objective information on positive and negative impact factors on clinical trials with medicinal products and on other types of clinical research
• reliable figures on the impact of the legislation on the clinical research activity of big Pharma Industry -, SME- and academia-sponsored trials
• evaluation of the resource, cost and effectiveness implication of the EU CTD implementation for all stakeholders
• comparison of the success of national CTD implementation
• consolidated conclusions on the findings amongst the stakeholders
• dissemination of the conclusions to the public at large

The Results

The Results of the Clinical Trials Directive research was broken down by stake holder:

Competent Authorities

• The vast majority (25 out of 28) of EU CAs participated in the survey. Two non-EU CAs from countries integrated within the EU regulatory system accepted to participate and provided responses.
• Content and quality of the responses varied greatly and were obviously dependent on the time, resources and systems the CAs had available to compile the information
• An impact on clinical research activity in the EU derived from the CTD implementation was apparent, though could not be readily confirmed from the available data
• No negative impact of the CTD on commercial sponsors could be detected. The number of CTAs submitted by commercial sponsors increased slightly (+11%) between 2003 and 2007
• Overall, a slight potential negative impact of the CTD on non-commercial sponsors was detected represented by a relative change of -25% of CTAs between 2003 and 2007, however, while some countries faced strong or even dramatic decreases other countries experienced an increase of non-commercial CTAs.
• The number of substantial amendments and SUSAR reports increased strongly after CTD implementation
• Average CTA timelines decreased after CTD implementation and were, in 2007, with 49 days clearly below the 60-day limit
• The indisputably increased administrative burden imposed by the CTD on the evaluation process and supervision of CTAs was reflected by an increase in workforces and related costs which was paralleled by a raise in fees

Ethics Committees

• Despite multiple contacts, the number of responding ECs was quite low
• The overall number of positive opinions increased by 23% between 2003 and 2007, with especially strong increases in CTs with medical devices and radiotherapy as well as non interventional/observational studies
• A huge increase in workload for ECs was observed since the implementation of the CTD, evidenced by not only the increase of opinions but also higher numbers of substantial amendments and SUSAR reports to ECs
• The number of negative opinions issued by lead or central ECs increased between 2003 and 2007 in line with the overall increase of reviews. More than 25% of responding ECs did not have an appeal system in place in 2007, but in countries where an appeal system was in place, it was significantly more frequently used than in 2003
• An increase in FTEs per EC was reported, however, the absolute numbers of employees per EC were still very low and often no clear differentiation was made between unpaid EC members and employees
• More than half of the ECs did not involve external reviewers in assessing applications despite the increasing complexity of the CTAs
• No differences could be detected in number of EC meetings and duration of review time per protocol between 2003 and 2007. However, the duration of the meetings increased slightly, but significantly
• Fees charged by lead or central ECs to commercial sponsors, SMEs and orphan drug trial sponsors for review of protocol and substantial amendments increased significantly from 2003 to 2007, but the fee level was different for these categories. The fee for academic trials was much lower and increased only slightly. Non-lead ECs did not charge significantly lower fees than lead or central ECs
• The annual budget of ECs increased by 50% between 2003 and 2007
• In 2007 ECs received final report summaries for less than 20% of the reviewed protocols
• 60% of responding ECs had no patient representative in their membership
• Especially non-lead/central ECs considered the procedure to generate a single opinion to be difficult

Commercial Sponsors

• The overall number of commercially-sponsored clinical trials increased by about 30%, driven by increases seen in large and medium-sized companies
• SMEs did not experience an increase but faced higher staff needs and related costs due to an increase in trial complexity
• Areas of relatively stronger increases were clinical trials with biotechnology products and with orphan indications
• Clinical trials were increasingly organized in more countries and more sites than before implementation of the CTD, however, the number of recruited patients increased only slightly
• There was no shift detectable in the responding companies in the type of trial phases performed in 2003 and 2007. However, generic companies did not participate in the survey because they reportedly do not perform their bioequivalence trials in Europe anymore
• Time lines for the overall protocol and substantial amendment approval process were extended by approximately 30%.
• Need for staff increase for preparation and management of clinical trials as well as for pharmacovigilance tasks, need for investment required to adapt IT systems to the new safety reporting requirements, and an increase of subject indemnity insurance fees added to an overall increase in resources required for the performance of clinical trials in the new regulatory environment without a demonstrable impact on improving patient safety
• In the opinion of commercial sponsors, the CTD has created a certain level of harmonisation of the clinical trials infrastructure in the EU, but as this harmonisation has not been sufficiently far-reaching, the complexity of clinical trials has increased

Non-Commercial Sponsors

• According to this survey’s data, the major impact of the CTD on the NCS activities was reflected in a significant increase of the workload and timelines, i.e., an increase in the time period before the entry of the 1st patient. The CA data did not show significant changes in the overall number of clinical trials conducted by NCSs. Overall, the CTD was perceived as having introduced a partial harmonisation of procedures, but this positive effect was heavily counterbalanced by the general lack of harmonisation, the increase of the administrative burden and related costs. NCSs called for simplified and harmonised requirements and sound
  risk based-approach
• A great heterogeneity was observed in the responses rates, the number of missing values, and the trends arising from the data collected from NCSs. These reflected the great heterogeneity of the NCS organisations, reaching from large research organisations and well-organised structures to small structures with a lower level of cooperative and dedicated resources. The capacity of NCSs to log critical information needs to be improved
• This survey was not designed for qualitative assessment of the impact of the CTD on the performance of future studies. The following questions need to be addressed: has the CTD improved patient protection and safety? What is the impact of the CTD on the quality of science: do we guarantee progress for patients in a timely manner? Can the nature of investigator-driven trials be preserved when independence from industry is threatened by the increasing burden of conducting such kinds of activities?
• A re-evaluation of the situation with respect to the implementation of the CTD and its impact would need to be performed over a 3-year time frame in order to take advantage of a more complete EudraCT database. The systematic comparison with the situation in non-EU territories, e.g. US, Canada and Japan, should also be included.

Overall Conclusion and Recommendation

ICREL provided strong arguments supporting some of the recommendations proposed by various stakeholders in scientific journals, at the EC-EMEA conference on the Directive (2007) and in the ESF “Forward Looks on investigator-driven clinical trials” (2009).

• A risk-based approach to regulation would result in a substantial reduction in workload and cost, particularly for academic institutions that run a number of low-risk studies using marketed drugs
• Simplification of the Clinical Trial Authorisation process by the competent authorities through a single CTA for multi-national trials would reduce duplication of efforts and also save time, costs, and expertise
• Harmonised practice in ethics committee requirements would facilitate and reduce the administrative burden of dossier submission, and changes in expedited SUSAR reporting to the ethics committees would alleviate their workload
• Insurance coverage for clinical trials should be reconsidered at the EU level and adequate funding should be provided to institutions performing clinical trials to ensure capacity and expertise for all trial-related activities

The above coments are form the Executive Summary and I woudl advice anybody with an interest in teh area to read the full report which is available from the ICREL site.

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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The pharmaceutical development section provides an opportunity present the knowledge gained with application of scientific approaches and quality and risk management of  the development of a product and its manufacturing process. This documentation is first produced for the original marketing application and can be updated to support new knowledge gained of the life-cycle of a product. the pharmaceutical development section is intended to provide a comprehensive understanding of the product and manufacturing process for reviews and inspectors. The guidance also indicate areas where the demonstration of greater understanding the pharmaceutical Manufacturing sciences can create a basis for flexible regulatory approaches. The degree of regulatory flexibility is predicted on level relevant scientific knowledge provided.

This guidance does not apply to contents of submissions of the drug product during the clinical research stages of drug development. However, the principles in this guidance are important to consider during all stages as well. This guidance might also be appropriate for the types of products.

The guidance goes through each of the sections in turn and describes the relevant content the regulators expect to see in that section:

• II a pharmaceutical development (2)
  • A. Component of the drug product (2.1)
    • 1. Drug substance (2.1.1)
    • 2. Excipients (2.1.2)
  • B. Drug product (2.2)
    • 1. Formulation development (2.2.1)
    • 2. Overages (2.2.2)
    • 3. Physicochemical and biological properties (2.2.3)
  • C. Manufacturing process development (2.3)
  • D. Container closure system (2.4)
  • E. Microbiological attributes (2.5)
  • F. Compatibility (2.6)

The guidance is so specific as to render any summary redundant readers are directed to download the entire document by clicking this link.

The bulk of changes to the document and incorporated in an annexe at the back of the guidance, this annex provides further clarification of key concepts outlined in Q8 pharmaceutical development. In addition, this annex describes the principles of quality by design. The annex is not intended to establish new standards or to introduce new regulatory requirements; however, it shows how concepts and tools outlined in the Q8 parent guidance could be put into practice by the applicant for all dosage forms.

this annex suggests strategic and quality systems that a company can adopt at the very start of the drug discovery programme, it describes approaches to pharmaceutical development, that the FDA and the International commission on harmonisation (ICH) would recommend for any company developing a pharmaceutical product with a significant commitment to quality. The guidance goes on to describe a number of elements that should be included at a minimum:

• quality target product profile (QTPP)
• critical quality attribute (CQAs)
• determination of critical quality attributes
• selection of appropriate manufacturing process
• risk assessment
• and definition of equality strategy

Each of these strategies in elements and described in some detail, the FDA go to great pains to point out that this is not a regulatory framework, better recommended system that they believe will ensure increased quality. I believe this documentation to be of such critical nature is to be recommended reading for anybody working in the area of drug development of discovery.

Please expect a more detailed review to this document to be published on this site.

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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The guidance document is a comprehensive document, and covers the regulations in some detail:

• The Medical Devices Regulations 2002
• The Active Implantable Medical Devices Directive
• Medical Devices Directive
• In Vitro Diagnostic Medical Devices Directive

The Guidance provides help interpreting these regulations in a number of Specific Areas:

• Clinical Investigtions in the UK
• Is a Clinical Investigation Required
• Special Clinical Investigations
  • Changes in intended use
  • Comparative Studies
  • Prototype Devices
  • Clinical Investigations also submitted to the FDA of other Non-EU Regulatory Authorities
  • In-house manufactured medical devices
  • “Off-Label” use
• Making an Application for Pre-clinical Assessment
• Competent authority processing of the clinical investigation
• Documentation required for all submissions
• Clinical Investigational Plans
• Documentation to be kept available
• Special features of clinical trials
• How your application will be handled by the UK-competent authority
• Adverse event handling

The publication is detailed and covers a number of areas in detail, it is recommended reading for anybody developing a medical device.

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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