On December 6, 2013 it was announced that a new patient safety legislation would be introduced known as the “Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law)”. The law Continue reading
Happy Holidays to our clients, friends, and family – wishing you a safe and enjoyable winter season.
As we welcome in the holidays we say goodbye to a phenomenal year that saw Regxia go through several pivotal changes that have allowed us to grow and strengthen our commitment to serve our clients.
This past year, we Continue reading
The revised procedural guidance European Medicines Agency Post-Authorisation Procedural Advice for Users of the Centralised Procedure is intended “to ensure that Continue reading
On June 2nd, 2014 the FDA announced the launch of openFDA, a new initiative designed to make accessing important public health data collected by the FDA easier for Continue reading
In order to provide industry with guidance on how to meet the BA and BE requirements as they apply to dosage forms intended for oral administration the FDA has published this draft guidance for general considerations. The guidance applies to Continue reading
Starting in August 2013, the EMA will begin reorganizing its structure. The main high-level changes are the replacement of the current two Units dealing with medicines for human use with four Continue reading
April 25, 2013, the European Medicines Agency’s (EMA) revisions to existing Good Pharmacovigilance Practice (GCP) guidelines will come into effect. The revisions include Continue reading
The purpose of the GCP guidance document is to provide interpretive guidance to industry on the expectations of inspectors with respect to the adverse drug reaction and post-approval reporting requirements when conducting GVP inspections. Continue reading
The European Medicines Agency has simplified the process of submission of applications for centrally authorised medicines, reducing the number of applications companies now need to submit. Continue reading
Health Canada has issued a new name for its Post-Market Reporting Compliance (PMRC) inspection program. The program will now be called Good Pharmacovigilance Practices (GVP) in order to harmonize its terminology with its international regulatory partners. Continue reading