Initiatives from regulators around the world seek to promote regulatory reliance at global level.
Reliance by regulators on inspection outcomes by agencies in other countries is among the topics discussed in a Q&A document published by the International Pharmaceutical Regulators Programme (IPRP).
Examples of such questions include what reliance is, its importance for the regulatory oversight of medical products, the main principles and
Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.
The European Medicines Agency is due to decide whether GSK’s previously approved multiple myeloma drug that was withdrawn from the market in 2022 should be approved again for use in combination with BorDex or PomDex. Meanwhile, Japan today became the second major regulator to approve the Blenrep combinations.
Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.
