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EMA Publish Concept Paper on Review of Guidelines on Influenza Vaccine Development

Posted on October 28, 2011 by admin| Leave a comment

EMA Publish Concept Paper on Review of Guidelines on Influenza Vaccine Development

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Regulatory requirements for the quality, non-clinical and clinical development of influenza vaccines are currently stated in several documents including multidisciplinary guidelines such as EMEA/CPMP/4986/03, CHMP/VWP/263499/06, the Note for guidance on harmonisation of requirements for influenza vaccines CPMP/BWP/214/96 and the Guideline on dossier structure and content for pandemic influenza vaccine marketing authorisation application (EMEA/CPMP/VEG/4717/03 rev. 1).

These guidelines were drafted and adopted at different time points and over several years before the onset of the 2009-2010 influenza pandemic and each addresses one of seasonal influenza vaccines, pre-pandemic or pandemic vaccines. The need to update the available guidelines regarding the manufacturing, non-clinical and clinical development of influenza vaccines was recognised during and  following the 2009-2010 influenza pandemic. More recently, issues encountered and experience gained during requests for CHMP scientific advice and the processing of several applications for marketing authorisation of influenza vaccines have underlined the desirability of updating the existing guidelines. In addition, it is anticipated that novel influenza vaccines could be based on e.g. recombinant proteins, virus-like particles (VLPs), DNA or live viral vectors and there is a need to consider the regulatory expectations that would apply to such products.
Although current and future influenza vaccines may vary in nature and composition they all aim to prevent clinically manifest influenza by means of eliciting a protective immune response. Therefore the
development of a single consolidated guidance document on the quality, non-clinical and clinical requirements for influenza vaccines seems to be both feasible and appropriate.



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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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FDA Publish Guidance on Container and Closure Systems Testing

Posted on October 28, 2011 by admin| Leave a comment

FDA Publish Guidance on Container and Closure Systems Testing

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This guidance document provides recommendations to you, manufacturers, for using methods other than sterility testing to confirm container and closure system integrity as a part of the stability protocol for sterile biological products, human and animal drugs, and medical devices. This guidance document finalizes the draft guidance of the same title dated January 1998 (January 28, 1998, 63 Federal Register (FR) 4272).
Manufacturers of drugs and biologics purporting to be sterile must test each batch or lot, as the case may be, to ensure that the product in question conforms to sterility requirements. 21 CFR 211.167(a); 21 CFR 610.12. Such drugs and biologics are also subject to stability testing requirements. 21 CFR 211.166. The stability testing requirements include maintaining a written testing program designed to assess stability characteristics. Manufacturers of medical devices must validate processes, including sterilization for a device purporting to be sterile. 21 CFR 820.75. Stability testing should be part of the design validation of such devices. In vitro diagnostic products for human use are required to be labeled with stability information. 21 CFR 809.10. For products labeled as sterile, we consider sterility to be a stability characteristic.
The purpose of stability testing is to provide evidence on how the quality of a substance or product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, which enables you to establish or modify recommended storage conditions, retest periods, and shelf life or dating period, as the case may be.2 This guidance document applies only to the replacement of the sterility test with an appropriate container and closure system integrity test in the stability written testing program (referred to in this guidanceas the “stability protocol”), recommending an alternative to sterility testing for supporting the continued capability of containers to maintain sterility. The guidance document does not apply to sterility testing methods for product sterility testing prior to release, as container and closure system integrity tests cannot demonstrate a product’s initial sterility.
This guidance document provides information that we recommend you consider when you propose using alternative methods to sterility testing to confirm the integrity of a container and closure system throughout the product’s shelf life or dating period. The recommendations in this guidance document apply to both pre- and post-approval stability protocols for sterile biological products, human and animal drugs, including investigational and bulk drugs. For medical devices, the recommendations in this guidance document apply to stability protocols for those devices labeled as sterile.
If you currently perform sterility testing as a stability-indicating test as part of a stability protocol, you may continue to do so. If your product is approved for an alternative to sterility testing as a component of your stability protocol, this document is not intended to recommend additional testing requirements.


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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 Publish Community Herbal Monograph on Fraxinus Excelsior L

Posted on October 27, 2011 by admin| Leave a comment

EMA Publish Community Herbal Monograph on Fraxinus Excelsior L

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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended
Fraxinus excelsior L. and Fraxinus angustifolia Vahl, folium (ash leaf)
i) Herbal substance
Not applicable.
ii) Herbal preparations
Comminuted herbal substance

Comminuted herbal substance as herbal tea (decoction or infusion) for oral use. The pharmaceutical form should be described by the European Pharmacopoeia full standard term.



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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 Publish Draft Guidelines on Clinical Investigations for Medicinal Products in Diabetes Mellitus

Posted on October 27, 2011 by admin| Leave a comment

EMA Publish Draft Guidelines on Clinical Investigations for Medicinal Products in Diabetes Mellitus

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Diabetes mellitus is a metabolic disorder characterised by the presence of hyperglycaemia due to defective insulin secretion, insulin action or both. The chronic hyperglycaemia of diabetes mellitus is associated with significant long term sequelae, particularly damage, dysfunction and failure of various organs – especially the kidney, eye, nerves, heart and blood vessels.
Type 1 diabetes is the result of pancreatic beta cell destruction and is prone to acute complications, such as ketoacidosis. In type 1 diabetes the main goal is optimal blood glucose control to be achieved by optimal insulin replacement therapy, extensive education and disease self management. Prevention of complications and management of pregnancy are important issues.
Type 2 diabetes is a complex disorder which involves various degrees of decreased beta-cell function, peripheral insulin resistance and abnormal hepatic glucose metabolism. Glucose control in type 2 diabetes deteriorates progressively over time, and, after failure of diet and exercise alone, needs on average a new intervention with glucose-lowering agents every 3-4 years in order to obtain/retain good control. Despite combination therapy and/or insulin treatment, a sizeable proportion of patients remain poorly controlled.
Overweight, hypertension and hyperlipidaemia are often associated with diabetes mellitus and multiple cardiovascular risk factor intervention is a key issue in type 2 diabetes. Therefore, global treatment aims in management of diabetes mellitus cover both lowering of blood glucose to near normal levels and correcting metabolic abnormalities and cardiovascular risk factors including weight management.

Indeed, it has been shown that normalisation or near normalisation of glucose levels (assessed by changes in HbA1c) in patients with type 1 and type 2 diabetes significantly reduces the risk of microvascular complications (retinopathy, nephropathy and neuropathy); the macrovascular risk reduction in patients with type 2 diabetes is less certain.
In children and adolescents, the diagnosis of diabetes type 1 and type 2 is similar to that in adults; however, the discrimination between them may not always be straightforward. Type 1 diabetes is the predominant form in children. Type 2 diabetes has been recently emerging among – mostly obese – children in puberty and may present with ketoacidosis as the first manifestation of the disease; an obese adolescent with hyperglycaemia may have either type 1 or type 2 diabetes. An important feature of type 2 diabetes in overweight/obese adolescents is the higher insulin resistance and faster beta cell destruction rate relative to adults.
Following may help discriminating between type 1 and type 2 diabetes and monogenic or other genetic non insulin-deficient diabetic forms in children and adolescents:

  • Disease definitions and methods of diagnosing defined in international treatment guidelines such as ADA recommendations or those of the International Society for Paediatric and Adolescent Diabetes for the diagnosis of diabetes in children and adolescence are based on presence or absence of obesity,
  • family history,
  • fasting insulin and C-peptide levels,
  • auto-antibodies
  • age of onset

This document provides guidance on clinical development programmes intended to support the registration of new medicinal products for the treatment, delay in onset or prevention of diabetes mellitus or preservation of beta-cell function in patients with diabetes.
These notes are intended to assist applicants during the development phase. Any deviation from guidelines should be explained and justified in the Clinical Overview.
Insulin delivery systems (including pumps, autoinjectors, prefilled syringes, etc.) are outside the scope of this document. Biosimilar insulins are covered by the Annex to Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues – Guidance on Similar Medicinal Products containing Recombinant Human Insulin CHMP/32775/05.



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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 Publish Guidance on the Qualification of Low Hippocampal Volume (atrophy) by MRI

Posted on October 27, 2011 by admin| Leave a comment

EMA Publish Guidance on the Qualification of Low Hippocampal Volume (atrophy) by MRI

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The European Medicines Agency’s (EMA) qualification process is a new, voluntary, scientific pathway leading to either a CHMP opinion or a Scientific Advice of novel methodologies on innovative methods or drug development tools. It includes qualification of biomarkers developed by consortia, networks, public/private partnerships, learned societies or pharmaceutical industry for a specific intended use in pharmaceutical research and development.
The Qualification team was: Prof. Fernando de Andrés Trelles (coordinator), Prof. Luca Pani (CHMP member), Dr Bertil Jonsson. The EMA Scientific Administrator for the procedure was Dr Maria Isaac.
On 23 March 2011 the Applicant C-Path CAMD Biomarker Working Group requested qualification advice for the Candidate Biomarkers of Alzheimer’s Disease (AD).
The procedure started during the SAWP meeting held on 26 – 28 April 2011.
The discussion meeting with the Applicant took place on 29 June 2011.
During its meeting held on 30 August – 01 September 2011, the SAWP agreed on the advice to be given to the Applicant. During its meeting held on 19 – 22 September 2011, the CHMP adopted the advice to be given to the Applicant. This advice is annexed to this letter.
The response given by CHMP is based on the questions and supporting documentation submitted by the Applicant, considered in the light of the current state-of-the-art in the relevant scientific fields.
The present opinion addresses the question as to whether the use of baseline measurement of low hippocampal volume (atrophy) by MRI are qualified in selecting (i.e. to categorize) subjects for trials in early Alzheimer’s Disease (AD) as having a high probability of being in the prodromal stage of the disease as defined by the Dubois Criteria (2007).
The vast majority of the data used in CHMP’s evaluation have been submitted by CAMD, the applicant that requested the qualification, and are all published literature available in the public domain. They have been supplemented by further information searched required by members of the qualification team.


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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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FDA awards three grants to stimulate development of pediatric medical devices

Posted on October 27, 2011 by admin| Leave a comment

FDA awards three grants to stimulate development of pediatric medical devices

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Grantees will work with industry and the FDA to address unmet pediatric device needs

The U.S. Food and Drug Administration today announced the awards of three grants to boost the development and availability of medical devices for children.

A panel of five experts with experience in medicine, business, and device development reviewed 10 applications for the grants, which will be administered by the FDA’s Office of Orphan Products Development. The recipients and grant amounts include:

• James Geiger, M.D. and Andre Muelenaer, M.D. of the University of Michigan Pediatric Device Consortium and the Pediatric Medical Device Institute Pediatric Medical Device Consortium, $1.1 million a year for two years.
• Michael Harrison, M.D. and the University of California, San Francisco Pediatric Device Consortium, $500,000 a year for two years.
• Barbara Boyan, Ph.D. and the Atlanta Pediatric Consortium, $900,000 a year for two years.

“Congress provides FDA with this funding so that we can help connect innovators and their ideas to experienced professionals who can assist them through development,” said Debra Lewis, O.D., acting director of the FDA’s Office of Orphan Product Development. “Development of medical devices for children lags up to a decade behind similar devices used in adults.”

Children differ in terms of size, growth, and body chemistry and present unique challenges to device designers. In addition, the activity level and ability to manage some implantable or long-term devices may vary greatly among children. While this program is administered by the Office of Orphan Products Development, it is intended to encompass devices used in all pediatric diseases, not just rare diseases.



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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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Getting the right balance – Guest Post

Posted on October 27, 2011 by admin| Leave a comment

Getting the right balance – Guest Post

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Personal development and emotional well being affect all areas of our lives. Emotional distress in your career can impact on your relationship with your children, problems at home can have a knock-on effect at work. It is reality that insists that we sometimes have to trade off a desire in one area of our life in order to satisfy another; personal development means being in control of making these choices and knowing that what you choose is right for you.

In order to know what to choose, what to sacrifice and what to pursue, think about the things that are important to you, in the various aspects of your life, your family, career, education, etc. and ask yourself “does this decision reflect what I feel is important to me?”, the action you take a in response to your answer will be self-evident.

To move forward with your own development, consider the level of satisfaction you have in your life right now, and how you can start to make changes to improve every aspect of your life.

If you would like to investigate how best you can personally move forward or you would like more information, please contact us at Heads for Living or click here.

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EMA Publish Guidance on SmPC for Plasma-Derived Fibrin Sealant / Haemostatic Products

Posted on October 26, 2011 by admin| Leave a comment

EMA Publish Guidance on SmPC for Plasma-Derived Fibrin Sealant / Haemostatic Products

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This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for plasma-derived fibrin sealant / haemostatic products.

The purpose of this core SmPC is to provide applicants and regulators with harmonised guidance on the information to be included in the Summary of product characteristics (SmPC) for plasma-derived fibrin sealant / haemostatic products.
The QRD product information template with explanatory notes (′QRD annotated template’)1 and the convention to be followed for QRD templates2 provide general guidance on format and text and should be read in conjunction with the core SmPC and the Guideline on summary of product characteristics3. It is very useful to provide information for health professionals on posology and method of administration at the end of the package leaflet since the SmPC is not always readily available. See the QRD annotated template for further guidance on how to present such information.
In addition, for the content of sections 4.4 and 4.8 concerning transmissible agents, refer to the current version of the Note for guidance on the warning on transmissible agents in SmPCs and package leaflets for plasma-derived medicinal products (CPMP/BPWG/BWP/561/03)4.
Timeline history of core SmPC: The original core SmPC (CPMP/BPWP/153/00) came into operation in January 2005. This revision concerns new statements in 4.4 and 6.6 for products recommended for use with gas pressurised fibrin sprayers.



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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 Publish List of References used in Assessment of Viola; Arvensis Murray, Vulgaris Koch

Posted on October 26, 2011 by admin| Leave a comment

EMA Publish List of References used in Assessment of Viola; Arvensis Murray, Vulgaris Koch

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The Agency acknowledges that copies of the underlying works used to produce this monograph were provided for research only with exclusion of any commercial purpose.
Allen DE, Hatfield G. Medicinal plants in folk tradition. Timber Press, Portland, Cambridge 2004, 111-112
Amenta R, Camarda L, Di Stefano V, Lentini F, Venza F. Traditional medicine as a source of new therapeutic agents against psoriasis. Fitoterapia 2000, 71:13-120
Bandyukova VA, Sergeeva N. Rutin in some cultivated plants. Khimia Prirododnich Soedinieni 1974, 4:524
Baszyński T. Zawartość tokoferoli (witaminy E) w kwiatach roślin łąkowych. Roczniki Nauk Rolniczych 1961, 74:757-762
Behmanesh Y, Abdollahi M. Haemolysis after consumption of Viola tricolor. WHO Drug Information 2002, 16:15-16
Bobowska M, Gobiec K, Grzęda W, Kempisty J, Sadowski Z. Poradnik Terapeutyczny. PZWL, Warszawa 1975, 408-409
Boruch T, Góra J, Bielawska M, Świątek L, Łuczak S. Extract of plants and their cosmetic application. Part XI. Extract from herb of Viola tricolor. Pollena: TSPK 1985, 82:38-40
Bradley PR. editor.Heartsease. Violae tricoloris herba. British Herbal Compendium. Vol 2. British Herbal Medicine Association, Bornemouth 2006, 207-210
Braun H. Heilpflanzen-Lexikon fűr Ärzte und Apotheker. Viola tricolor. Feldstiefmütterchen. Gustav Fischer Verlag, Stuttgart 1974, 197
Brinker F. Herb contraindications and drug interactions. Appendix A. Herbs to be used with caution. Eclectic Medical Publications 2001, 209-211….


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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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MHRA Publishes Updated Advertising of Medicines Guidance

Posted on October 26, 2011 by admin| Leave a comment

MHRA Publishes Updated Advertising of Medicines Guidance

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This guidance has been developed by the Medicines and Healthcare products Regulatory Agency (MHRA) and is supplementary to the regulatory framework as set out in the Medicines (Advertising) Regulations 1994 (“the Advertising Regulations”, SI 1994/1932 as amended) which implement Titles VIII and VIIIa of European Directive 2001/83/EC. General advice on compliance with the Advertising Regulations is given in the MHRA Blue Guide.
The internet is used widely to provide information to consumers and to promote products and services. This guidance is intended primarily for companies and organisations which do not hold marketing authorisations for medicines but which provide services that may lead to the prescription and supply of a prescription only medicine (POM). The guidance seeks to ensure that the content of such websites does not contravene the Advertising Regulations. In particular, it highlights the prohibition by regulation 7 of the Advertising Regulations of advertisements to the public likely to lead to the use of a POM. It is designed to help advertisers to promote their services without promoting specific POM medicines and thereby coming within the scope of the Advertising Regulations.
If a complaint is received, the decision on whether a particular website complies with the Advertising Regulations will be taken by the MHRA on a case by case basis, having regard to the circumstances of the particular case.


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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 Publish Concept Paper on Need for New Guidance on Nociceptive Pain

Posted on October 25, 2011 by admin| Leave a comment

EMA Publish Concept Paper on Need for New Guidance on Nociceptive Pain

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Pain is the most common symptom for which patients seek medical attention. Although there is no exact definition it has been defined as an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage (International Association for the Study of Pain (IASP). Due to the subjective component of pain and the problems associated with a correct diagnosis patients are frequently undertreated for acute and chronic situations.
Nociceptive and neuropathic pain has been internationally defined. Nociceptive pain can be defined as the process by which intense thermal, mechanical, or chemical stimuli are detected by a subpopulation of peripheral nerve fibers, called nociceptors whereas neuropathic pain can be defined as pain arising as a direct consequence of a lesion or disease affecting the somatosensory system. In addition, pain can be of mixed origin (e.g. cancer pain), thus justifying that the 2 current guidelines are merged in a unique document. When current guidelines on nociceptive and neuropathic pain were written, the experience on clinical development was not large.
The different types of pain which may have different pathophysiological mechanisms and pathways should be considered in the clinical development of new analgesic agents, and the proposed models to evaluate treatment efficacy should be updated in line of the experience gained during the past years.
Fibromyalgia is a complex disease with clinical features other than pain and should be dealt with in a separate document.



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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 Publish Assessment Report on Viola Tricolor L.

Posted on October 25, 2011 by admin| Leave a comment

EMA Publish Assessment Report on Viola Tricolor L.

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The herbal substance of wild pansy and/or European field pansy is mentioned in several well known handbooks such as Madaus (1938), Martindale (2007), Wichtl (1994; 2004), PDR for Herbal Medicines (2000; 2004), German Commission E Monograph, European Pharmacopoeia 6.0, Duke’s Handbook of Medicinal Herbs (2002), Hänsel et al. (1994) and Chevallier Encyclopedia of Medicinal Plants (1996).
In the European Pharmacopoeia it is described as the dried flowering aerial parts of Viola tricolor L. (wild pansy) and/or spp. Viola arvensis Murray (Gaud.) and Koch (Oborny) (European field pansy). Wild pansy must contain at least 1.5 percent of flavonoids, calculated with reference to the dried substance, expressed as violanthin.
Wild pansy belongs to the family of Violaceae. The herb is distributed in Europe and Asia. Flowering aerial parts of wild pansy are harvested during summer.



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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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FDA Publishes Staff Guidance on De Novo Classification and Evaluation Class III Devices

Posted on October 25, 2011 by admin| Leave a comment

FDA Publishes Staff Guidance on De Novo Classification and Evaluation Class III Devices

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The purpose of this document is to provide guidance on the process for the submission and review of petitions under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), also known as the de novo classification process. This process provides a route to market for medical devices that are low to moderate risk, but that have been classified in class III because FDA has found them to be “not substantially equivalent” (NSE) to legally marketed predicate devices.



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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 Publish Overview of Comments Received on Community Herbal Monograph for Viola Tricolor L.

Posted on October 24, 2011 by admin| Leave a comment

EMA Publish Overview of Comments Received on Community Herbal Monograph for Viola Tricolor L.

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Organisations and/or individuals that commented on the draft Community herbal monograph on Viola tricolor L. and/or subspecies Viola arvensis Murray (Gaud) and Viola vulgaris Koch (Oborny), herba cum flore as released for public consultation on 11 March 2010 until 15 August 2010.
Organisations and/or individuals
1 European Scientific Cooperative on Phytotherapy (ESCOP)


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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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FDA Publish Guidane on Media Fills for PET Drugs

Posted on October 24, 2011 by admin| Leave a comment

FDA Publish Guidane on Media Fills for PET Drugs

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This guidance is intended to help manufacturers of positron emission tomography (PET) drugs meet the requirements for the Agency’s current good manufacturing practice (CGMP) regulations for PET drugs (21 CFR part 212). Most PET drugs are designed for parenteral administration and are produced by aseptic processing. The goal of aseptic processing is to make a product that is free of microorganisms and toxic microbial byproducts, most notably bacterial endotoxins. A media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium, in place of the drug solution, to test whether the aseptic procedures are adequate to prevent contamination during actual drug production.



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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 Publish Concept Paper on Bio-Similar products containing Active Proteins: Clinical and Non-Clinical

Posted on October 24, 2011 by admin| Leave a comment

EMA Publish Concept Paper on Bio-Similar products containing Active Proteins: Clinical and Non-Clinical

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The Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMEA/CHMP/BMWP/42832/2005) lays down the  nonclinical and clinical requirements for a biological medicinal product claiming to be similar to another one already marketed. This guideline came into effect in June 2006. Since then several biosimilar  products have come into the EU market, the number of scientific advices given by the CHMP on the development of biosimilar products has increased significantly and the regulatory framework is becoming wider, e.g. the draft guideline of the biosimilar monoclonal antibodies is being finalised.

An increasing number of biosimilar products are under development, especially biosimilar monoclonal antibodies. The development of more complex biosimilar medicinal products is challenging, and several issues in the development are under re-evaluation. These include the selection of relevant species for non-clinical studies, need for clinical equivalence studies and other issues of the design of the pivotal clinical studies, role of biomarkers, amount of immunogenicity data needed, and the possibility to extrapolate to other indications. The WHO Guidelines on Evaluation of Similar Biotherapeutic Products with detailed recommendations on clinical development were published in October 2009. In addition, the EMA is emphasizing the need to follow the 3 R principles (replacement, reduction and refinement) with regard to the use of animal experiments. All these factors suggest revising the current guideline.



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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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Health Canada Publishes a Document on Reviewing the Medical Device Inspection Cycle

Posted on October 23, 2011 by admin| Leave a comment

Health Canada Publishes a Document on Reviewing the Medical Device Inspection Cycle

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Health Canada is in the process of creating a Medical Devices Inspection Cycle. Our goal is to make this inspection cycle risk-based. This document provides potential options in inspecting scheduling and cycles.
We are exploring changes and we would appreciate your input on key concepts that we are considering. Specially, we welcome input on (i) how we assess the risk of an establishment; (ii) appropriate inspection cycles for different levels of risk.
The following suggestions may help you prepare your comments:

  • Please explain your views as clearly and concisely as possible.
  • Be sure to distinguish between what you support and what you object to in this document.
  • Provide rationale for your views, particularly your concerns, with facts, data or specific examples.
  • Describe any assumptions that you made.

Please submit your comments by November 16, 2011.
In order to provide your comments you must submit them by sending the Word or PDF format and email them to the mdcu-ucim@hc-sc.gc.ca.
Please note that any information collected will only be used for input to this consultation. The information collected will be used to create a summary report and will guide recommendations made as part of this review. The summary report will be made available to stakeholders once consultations are complete.



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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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Twitter Weekly Updates for 2011-10-23

Posted on October 23, 2011 by admin| Leave a comment

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FDA Publish Guidance on Time and Extent Applications for NonPrescription Drug Products

Posted on October 23, 2011 by admin| Leave a comment

FDA Publish Guidance on Time and Extent Applications for Non Prescription Drug Products

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This guidance is intended to explain what information an applicant should submit to the Food and Drug Administration (FDA) to request that a drug product be included in the over-thecounter (OTC) drug monograph system and to describe the process for submitting that information. FDA regulations set forth criteria and procedures by which OTC drugs that initially were marketed in the United States after the OTC drug review began in 1972 and OTC drugs without any U.S. marketing experience can be considered for inclusion in the OTC drug monograph system (21 CFR 330.14). The regulations establish a two-part process. First, to determine whether a drug product is eligible to be considered for inclusion in the OTC drug monograph system, certain information must be submitted in a time and extent application (TEA) to show that a drug product can meet the statutory standard of marketing to a material extent and for a material time.2 Second, if the drug product is found eligible to be considered for inclusion in the OTC drug monograph system, we will publish a notice of eligibility in the Federal Register that requests that interested persons submit data to demonstrate the safety and effectiveness of the drug product for its OTC use(s) (21 CFR 330.14(e) and (f)).

This guidance describes the format and content of a TEA that is used to determine if a drug has been marketed OTC to a material extent and for a material time, and what happens after a TEA is submitted. Drug products covered by this guidance are those OTC drug products that: (1) were initially marketed in the United States after the OTC drug review began on May 11, 1972; or (2) are without any U.S. marketing experience.


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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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Key references and local legislation for PIL User Testing: Europe

Posted on October 22, 2011 by admin| Leave a comment

Key references and local legislation for PIL User Testing: Europe

article by Associate Consultant Mark Gibson

The following document was included in a market analysis report compiled in July 2009. As such, some recent developments, such as the Lithuanian readability testing guidance and the Romanian accreditation guidance are not included.  Neither are any of the guidance published by countries, such as Croatia and Ukraine. All of the above are subjects currently being written up as separate blog articles…so, watch this space!  Nevertheless, a lot of the references included in this article might still be useful.


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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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