Tag: Regulatory

European Commission released action plan on paediatrics

pills
The European Medicines Agency and the European Commission’s Directorate-General for Health and Food Safety have published a joint action plan to support the development of medicines for children.

EMA launches a new version of its website

ema
The European Medicines Agency (EMA) has launched a new version of its corporate website. The website has a number of new features to improve user experience.

SID & GP took part in the International Conference of Drug Regulatory Authorities

pharma
Representatives of the Russian Ministry of Industry and Trade and the State Institute of Drugs and Good Practices participated in the International Conference of Drug Regulatory Authorities (ICDRA).

EU regulators published their work programme for 2019/20

European-Commission
The task force set up by European Union (EU) regulators to better address potential problems with medicines’ supply and to avoid shortages published its work programme for the coming two years.

UK will accept EU-based batch testing of medicines

pills
European pharmaceutical companies will be able to supply their medicines in the UK on the basis of approved batch testing carried out in the EU for at least two years.

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

eu-us
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

drugs
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

ema
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

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-Commission
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

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