Tag: Regulatory

EMA and FDA will conduct workshop on PRIME and Breakthrough Therapy schemes

EMA and FDA launched PRIME and Breakthrough Therapy schemes to strengthen their support to the development of medicines for unmet medical needs to help patients to benefit from these therapies as early as possible.

EU and Japan strenghten collaboration on inspections of drug manufacturers

The European Union (EU) and Japan have agreed to broaden the range of medicines for which they will recognise each other’s inspections of manufacturing sites.

EMA published report on the International API inspection programme

The European Medicines Agency (EMA) and its European and international partners have successfully strengthened their interactions to improve the oversight of active pharmaceutical ingredient (API) manufacturers worldwide.

Wickham Labs will hold a webinar on the regulatory demands for medical devices

Wicham Labs, a contract testing laboratory, announced its upcoming webinar, “Regulatory Changes in Medical Device Development” which will take place on 23rd of May 2018.

China established a new drug regulator

china street
After about five years as a standalone agency, the China Food and Drug Administration (CFDA) will merge into a gigantic national market supervision administration, with drug regulation as a new, second-tier bureau underneath.

EMA discussed its future premises in Amsterdam

european medicines agency
The European Medicines Agency’s Management Board met in an extraordinary session to discuss EMA’s future premises in Amsterdam. EMA will move from London to Amsterdam before the end of March 2019.

European Comission published a report on falsified medicines

European comission published a report on the application of penalties for those involved in the production and circulation of falsified medicines published. The report shows a wide variation in penalties across the EU.

Key regulatory developments in the Russian life-sciences sector – December 2017

Maria Borzova, council of Trubor law firm, goes over the most important life-science regulatory updates.

PhEB: Pre-authorization Issues of Placing Pharmaceuticals on the Market

This is a Special Video Series describes general regulatory framework and main pre-authorization issues, including GMP certification, non-clinical, and clinical testing

EMA published a set of GMP guidelines for advanced therapies

european medicines agency
The European Commission has published a set of guidelines on good manufacturing practice specific to advanced therapy medicinal products

EMA launched an improved version of EudraVigilance information system

The European Medicines Agency has launched a new and improved version of EudraVigilance, the European information system

Kazakhstan’s Center for Expertise of Medicines joined IPRF and IGDRP

kazakhstan drug quality control
The meetings of the Management Committee of IPRF and the Steering Committee of IGDRP approved the admission of the Kazakhstan’s Center to IPRF and IGDRP

EMA and EUnetHTA published a new joint work plan

european medicines agency
The European Medicines Agency and the European Network for Health Technology Assessment have published a joint work plan outlining key areas of collaboration

VEGAS Academy: Russian pharmaceutical sector regulatory news, Sept 2017

https://www.youtube.com/watch?v=PUJqe6otywA Here at VEGAS academy, we are continuing our monthly series of video commentary related to the key regulatory changes in Russian pharmaceutical industry....