On January 31, 2017, the French National Drug and Health Product Agency ("ANSM") issued an updated FAQ related to the authorization and declaration procedures of manufacturing, import, and distribution of raw materials for...more
On April 27, 2017, the European Medicines Agency ("EMA") held a meeting with the heads of the National Competent Authorities ("NCAs") of the European Union ("EU")/European Economic Area ("EEA") Member States to discuss the...more
5/12/2017
/ Biosimilars ,
EU ,
European Commission ,
European Economic Area (EEA) ,
European Medicines Agency (EMA) ,
Life Sciences ,
Medical Devices ,
Member State ,
Pharmaceutical Industry ,
Regulatory Standards ,
UK Brexit
On April 6, 2017, the European Medicines Agency ("EMA") issued new guidance and recommendations concerning periodic safety update reports ("PSURs") of nationally authorized medicinal products. These recommendations form part...more
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK's pharmaceutical and medical devices regulator, has recently released its 2017-2018 business plan. Of the 10 key priorities identified by the MHRA, life...more
FDA Amends Waivers to Sanitary Transportation Rule -
On April 6, 2017, the Food and Drug Administration ("FDA") notified industry regarding the amendment of waivers available under the Sanitary Transportation of Human...more
4/13/2017
/ Animal Food ,
Annual Reports ,
Chemicals ,
EU ,
European Food Safety Authority (EFSA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
FSMA ,
Imports ,
National Security ,
Pesticides ,
Sanitary Food Transportation Act (SFTA)