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!