Therapy development is not only time consuming and costly, but also highly regulated. New therapies can only become accessible to patients, if data and results from (pre-)clinical trials demonstrate that the therapy is of sufficient quality, has a favourable benefit-risk ratio for patients and is cost-effective. To ensure that new therapies reach patients efficiently, it is important that regulatory pathways and requirements are flexibible and adaptive to enable the implementation of new methods and the evaluation of new therapies based on innovative technologies and state-of-the-art science. You can pose all your questions related to the different therapy development stages in this category. Please use tags to cross reference to other categories.
Useful links
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
THE ICH brings together the regulatory authorities and pharmaceutical industry to discuss and harmonize scientific and technical aspects of drug registration. Harmonisation is achieved through the development of ICH Guidelines via a process of scientific consensus with regulatory and industry experts working side-by-side. The ICH guidelines are divided in four categories:
- Quality guidelines (Q)
- Safety guidelines (S)
- Efficacy guidelines (E)
- Multidisciplinary guidelines (M)
For many of the guidelines there is free of charge training material available,
CCMO video - Hoe ga je als academische onderzoeker te werk als je je onderzoek wilt laten toetsen? (Dutch only)
Setting up a clinical study is complex and involves a lot. It can also be difficult to find your way in the world of ethical review. With this animation, the CCMO gives you more information and tools.
Guidance and direction from EMA
At any stage of a medicine’s development, you can ask guidance and direction from EMA on the best methods and study designs to generate robust information on how well a medicine works and how safe it is.
- EMA’s interactive journey of therapy development
This interactive tool describes the journey of a medicine authorised via the Agency, from initial research to patient access in the EU, and how EMA works. - Infosheet - Tools available to medicine’s developers from the academic sector
Overview of EMA tools to support (academic) therapy developers. - EMA User guide micro small and medium sized enterprises
This guide is developed to facilitate understanding of the main aspects of medicinal product legislation. - PRIME is a scheme to support the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier.
- ITF is established to provide support to medicines innovation in EU and focuses in particular on Emerging Therapies and Technologies.
National or decentral marketing authorisation via the CBG-MEB
- MEB Application compass of the National Medicine Evaluation Board of the Netherlands (CBG-MEB) provides a nice overview of the steps that need to be taken prior to the application, the different application procedures, the different types of marketing authorisation, what is needed for the application dossier, etc…
- CBG-MEB planning tools if you are planning to apply for a procedure (i.a. marketing authorisation, scientific advice) check these planning tools!
- Overview fee rates for procedures
Frequently asked questions about Active Pharmaceutical Ingredients (APIs) on the website of the IGJ (in Dutch).