EFCG Calls for Inspections of API Manufacturers - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

EFCG Calls for Inspections of API Manufacturers


ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Fine Chemicals Group (EFCG) has proposed that mandatory inspections be introduced for all global API manufacturers wishing to supply the EU market. EFCG believes that such inspections will help to harmonize the global rules and regulations concerning APIs and pharmaceutical products.

The group proposes that inspections be conducted using a Mutual Recognition Agreement (MRA) approach involving national regulatory authorities sharing inspection resources. An EFCG position paper estimates that the cost of inspections will be approximately EUR 2.6 million ($3.3 million) over a three-year period and suggests that financial resources could come from participating companies wishing to sell their APIs in the EU marketplace.  

During the past decade, the market for generic APIs has increased and a greater number of APIs used in European medicines are sourced from China and India. API manufacturers in these countries, however, are rarely inspected by EU authorities. In a position paper, EFCG claims that 70% of all APIs consumed in Europe are imported from China and India. With the vast majority of manufacturers unregulated, some APIs may contain impurities or may be in breach of EU quality standards. Cases cited by the position paper include glycerine contaminated with antifreeze (2006), heparin contaminated with chondroitin sulphate (2008) and contaminated cardiovascular drugs in Pakistan (2012).

Assuming 860 API manufacturing sites were inspected once every three years by 33 inspection authorities (EU (27), USA, Australia, Japan, Switzerland, new Zealand, Canada) to the same standard (ICH Q7) and that they are willing and able to share the inspection outcomes, then around 8 sites need to be inspected each year by each inspection authority, states the position paper.

EFCG has been calling for mandatory inspections of all global API sites since 2004.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here