Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

New Dosage Forms of Old Substances - Regulatory Strategies and Challenges in the European Union ***

Dr. David Thalmann (Abschlußjahr: 2021)

Summary
Language: English
The European regulatory landscape offers some good opportunities for new pharmaceutical forms of known active substances. Current regulations allow marketing authorisation applications to rely on reference medicinal products or on published data. This reduces developmental efforts for new products. Furthermore, a wide range of scientific guidelines relevant to the development of new pharmaceutical forms of known active substances are available, reflecting current scientific knowledge and the expectations of regulatory authorities. This helps applicants to align their development processes and make them more efficient.
However, there are some challenges for new pharmaceutical forms of known substances in the EU. One of the most important is the limited eligibility for data exclusivity or market protection even if the new pharmaceutical form comes with a significant clinical benefit. There are only two options to achieve additional regulatory protection for new pharmaceutical forms of known active substances, both of which fall to short: the introduction of a new indication according to Article 10(5) of Directive 2001/83/EC and the use of the PUMA according to  Chapter 2 of Regulation (EC) No 1901/2006. Whereas the shortcomings of the paediatric regulation have already been acknowledged and proposals for a revision are ongoing, no attempts are made to improve the incentive and reward system for new medicinal products of known substances that cover an unmet clinical need in adult non-rare disease indications.
A proposal is made for an holistic approach harmonising the reward and incentive system for all products covering unmet clinical needs in the EU irrespective of the target population. This does not mean to give up the specific fostering of the development of paediatric medicines but to integrate it into the larger context of unmet clinical needs. Care should be taken that incentives and rewards granted in such a system equally apply to products irrespective of their type, i.e. new vs. known active substances.
Pages: 49
Annexes: none