GMP News - Regulatory Affairs

Strict requirements have to be complied with when submitting a dossier for the application of a new CEP. Read more about the changes recently published in a revised Policy of the EDQM on restrictions regarding substances.

In the near future, extensive stability data on the medicinal product and the API should be submitted for the application of generics in the USA. The FDA has recently published a draft guideline for comment. More details about the new requirements can be found here.

The EMA has published the European Union regulatory network incident management plan for medicines for human use, explaining how the EMA, the European Commission and medicines regulatory authorities work together in the EU Member States. Read more.

From FDA's point of view, the science exists to enable continuous manufacturing in the pharmaceutical industry and there are no regulatory hurdles for implementing it. However, there is a lack of necessary experience. Read more in this News.

As of 1 October 2012, the FDA can collect fees from generic drug companies for the processing of marketing authorisation applications.The authority can further collect fees for the performance of inspections of generics manufacturers and API suppliers of the generic industry. The reason for this is the enactment on 9 July of the "Generic Drug User Fee Act" (GDUFA) by the Congress. More details about the new act can be found here.

The FDA has approved the first over the counter HIV Test to be performed at home. Read more here.

The European Medicines Agencvy (EMA) has published two modules of guideline on good pharmacovigilance practices released for public consultation. Read more.