GMP for APIs

Canada to adopt ICH GMP guideline for veterinary products

The Veterinary Drugs Directorate (VDD) at Health Canada has issued a notice of its intention to adopt the GMP guideline for active pharmaceutical ingredients (APIs) developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), for APIs used in veterinary products (ICH Q7A)1,2. The directorate intends to adopt the guidelines developed for human medicinal products as its principles and practices are internationally recognised as having relevance to APIs for veterinary use. Comments on the adoption of the guidelines for veterinary APIs should be submitted to the VDD by 27 February 2004.

This follows an announcement issued in December 2002 of Health Canada's intention to adopt ICH Q7A for APIs for human...

Welcome to Pink Sheet

Create an account to read this article

More from Archive

Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By 

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By 

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 

A new pilot aims to take Brazil closer to ‘digital transformation.’

More from Pink Sheet

EU Critical Medicines Act May Include Investigational Products & Mandatory Redistribution Measure

 

The inclusion of investigational drugs in the Critical Medicines Act and new provisions on stockpiling are among the raft of amendments the European Parliament has made to the draft legislation.

EU HTA Regulation: Key Gaps Identified In Support For Small Companies And Experts

 

A meeting between the European Commission and industry stakeholders has revealed several areas of importance and lessons learned in relation to the EU Health Technology Assessment Regulation, which began to apply to certain medicinal products this year.

89 Complete Response Letters For Unapproved Drugs, One Huge Leap For US FDA Transparency

 

The US FDA’s unprecedented publication of 89 recent CRLs for unapproved products comes with a promise to release future letters more promptly.