There are potential changes under consideration as described here . The article also contains a link to a clear review of the current situation. Hope this is of use.
For any new Marketing Authorisation (MA) application, the applicant’s choice both of the legal basis and of the application submission procedure is important. Decisions about these subjects can impact significantly on pharmaceutical and other development work, on a variety of pre-licensing submission activities, on eventual marketing opportunities and on the potential for product family enlargement.
“Full” MA applications such as are required for New Drug Products (which are those that contain a New Drug Substance) have to be supported by large amounts of relevant experimental, scientific and clinical data to support the Quality, Safety and Efficacy of the New Drug Product.
“Abridged” MA applications are less than “Full” but must also satisfy the licensing authorities with regard to Quality, Safety and Efficacy. This can sometimes be done in different ways.
‘Generic Products’ form a particular and very important category of “Abridged” applications.
Use of generic medicines is now central to many people’s care, particularly in the UK where a growing number of people diagnosed with a long-term condition (e.g. diabetes, cardiovascular conditions, mental illness) can be treated less expensively than with innovator medicines. The considerable savings [£9.6 billion per year just in England & Wales alone, according to British Generic Manufacturers Association (BGMA)] can be diverted towards other forms of healthcare including the use of New Drug Products. It is also interesting to note the BGMA’s figures showing that the average cost to the UK National Health Service (NHS) of a branded medicine is £19.73 in contrast to £4.01 for the average cost of a generic medicine.
Increasingly, EU health budgets outside the UK are also benefitting from lower costs of medicines achieved through generic prescribing and dispensing. An overall consequence is that in the EU the reduced cost of medicines (amounting to billions of pounds and billions of euros) allows more patients to be treated and also releases resources which are in turn invested in new and innovative treatments for patients.
It’s therefore not surprising for the above reasons and more that the EU considers that Generic Medicines are important enough to have special legislation facilitating their development and approval. As a result MA applications for generic medicines benefit from a legal derogation whereby the results both of pre-clinical (non-clinical) tests and of most clinical trials “shall not be required”. However, applicants for MAs for Generic Medicines are not excused from providing satisfactory results from relevant pharmaceutical testing.
There is a number of special requirements expected of Generic Product manufacturers that have been laid down in EU legislation and interpreted through various, indeed many, official guidance documents. The key subjects have complexities that need to be learned, understood and satisfied by the generics industry guided by their regulatory affairs staff. Expert training about pharmaceutical testing and about generic product specifics is available (see www.pharmaqmtraining.eu) to interested parties from distinguished speakers such as:
Derek Calam who is a Visiting Professor of Pharmaceutical Sciences, University of Strathclyde, a Member of the WHO Expert Panels for both Pharmaceuticals and Biologicals and Chairman of the WHO Committee responsible for allocating names to medical substances on a global basis, a UK-nominated Expert at the European Medicines Agency (EMA) in London, and much more.
Formerly Head of Chemistry Division at the National Institute for Biological Standards and Control, formerly Chairman of the European Pharmacopoeia Commission and of the British Pharmacopoeia Commission, formerly Chairman and Member of the EDQM Steering Committee for Certification, Strasbourg.
David Snodin who is Principal, Xiphora Bipharma Consulting, a Fellow of the Royal Society of Chemistry, a Member of The Organisation for Professionals in Regulatory Affairs and a Registered Euro Toxicologist. David is recognised internationally for his insight, foresight and great expertise on the control of genotoxic and other impurities in innovator and generic products. He is an experienced international lecturer and author/co-author of many modern scientific papers on Safety Evaluation of Biopharmaceuticals and other products including generic medicines.
Working formerly in the food and pharmaceutical industries, David then joined the UK Licensing Authority (now the Medicines and Healthcare products Regulatory Agency (MHRA)] where he became an Expert Preclinical Assessor and the UK representative on the CPMP Safety Working Party. David then worked for PAREXEL Drug Development Consulting for over 8 years where he was Vice President Nonclinical before establishing Xiphora Bipharma Consulting.
Paul Fleming who is Technical Director of the BGMA (which represents and promotes the views of the generic medicines industry in UK and has close and regular discussions with MHRA, other parts of the Department of Health and the NHS) and at a European level, a key Member of the Regulatory Committee of the European Generic Medicines Association, EGA. In both these roles, Paul is involved in the development and implementation of new regulatory guidance. Paul is an Expert to the British Pharmacopoeia Commission. He is an experienced and accomplished Lecturer.
Formerly, Paul worked for the generic sector of the pharmaceutical industry in Europe in a variety of senior board level roles covering drug regulation, pharmacovigilance and formulation development and he was a Pharmaceutical Assessor at the MHRA.
Learn from these respected scientists with their amazing collection of experience and expertise! Network with them at training sessions, ask the questions you puzzle over and boost your knowledge, understanding, competences and confidence.
By the way, the title at the top of this blog post is my prediction of your feedback comments after you have completed one or both of my Summer Courses in London!
A Short Course on Regulatory Affairs with emphasis on
Understanding ‘Small Molecule’ Generic Medicines
12-13 October 2011
Legacy Falcon Hotel, Stratford-upon-Avon, United Kingdom
This will be a comprehensive course that blends EU pharmaceutical legislation, legal base and other official requirements and guidelines with appropriately-focused elements of pharmaceutical science, nonclinical and clinical investigations that are important to the development and licensing of generic medicines in Europe.
Building from first principles in several disciplines, delegates will learn about many important aspects of pharmaceutical development, manufacturing and control of the dosage forms, what comparator products are acceptable and the importance of comparative impurity profiles and of key pharmacokinetic parameters.
Submissions (MAAs) for generic medicines must have a substantial Common Technical Document (CTD) Module 3 and much attention in the course will be given to the Chemistry & Pharmacy components. However, some Module 4 and 5 issues will also be addressed, with emphasis on Qualification of impurities and on the importance of bioequivalence study report which has to be lodged in CTD Module 5.
The Course Leaders have years of experience as Assessors and Advisers to European Authorities and aim to guide you to a much better understanding of what is expected in Regulatory Applications for these important pharmaceutical products.
This course is suitable for people (likely to be from analytical, formulation, pharmaceutical development, manufacturing and regulatory/registration departments) needing to understand Abridged Applications for generic and other medicines. It will also be useful to people who want better to understand regulatory science and scientific writing and other skills needed for the creation of successful licensing dossiers.
If you want to improve your understanding of these complex issues, why not take a more detailed look at the course agenda. It is only a small document to read now but be assured that the course is comprehensive and will give you great insight into the subject.
I hope to be able to welcome you to the two-days course at the 4-Star Legacy Falcon Hotel in October 2011. Check our conference package for its amazing value! Probably your only extras will be your travel costs!
Listed below are a few questions for you to consider.
1. GENERIC COMPANY APPLICANTS FOR MARKETING AUTHORISATIONS AVOID REPEATING PRE-CLINICAL AND CLINICAL STUDIES PERFORMED BY THE ORIGINATOR COMPANY.
DO YOU KNOW HOW THIS CAN BE DONE WHILST STILL ACHIEVING YOUR MARKETING OBJECTIVE?
2. HOW DO YOU OR WILL YOU CHECK THAT A VENDOR OF A DRUG SUBSTANCE IS A SUITABLE SOURCE OF SUPPLY?
3. WHAT IS BEING PROPOSED TO STOP INAPPROPRIATE PRODUCTS (DRUG SUBSTANCES, EXCIPIENTS AND DOSAGE FORMS) ENTERING THE SUPPLY CHAIN?
4. ARE YOU FAMILIAR WITH THE PEDIGREE OR TRACEABILITY CONCEPT? ARE YOU FAMILIAR WITH THE UPCOMING CHANGES INTENDED TO ADDRESS CONCERNS ABOUT FALSIFIED ACTIVE SUBSTANCES AND FALSIFIED MEDICINAL PRODUCTS?
These and many other subjects will be the subject of Expert and up-to-date presentations by Paul Fleming, the Technical Director of the British Generic Manufacturers Association (BGMA), and our other Expert Speakers.
BGMA represents and promotes the views of the generic medicines industry in UK and has close and regular discussions with the Medicines and Healthcare products Regulatory Agency (MHRA) and various parts of the UK Department of Health and National Health Service. At a European level, he is a key Member of the Regulatory Committee of the European Generic Manufacturers Association, EGA. In both these roles, Paul is involved in the development and implementation of new regulatory guidance.
You can still book your place on the PharmaQMtraining.eu course “Regulatory Affairs with emphasis on UNDERSTANDING ‘SMALL MOLECULE’ GENERIC MEDICINES” running next on 12-13 October 2011, at Legacy Falcon Hotel, Stratford-upon-Avon, United Kingdom.
Please visit http://www.pharmaqmtraining.eu/course_schedule.html where you can access more information and a booking form. Paul and our other Expert Speakers look forward to meeting you and answering your questions.