The rules on importing active pharmaceutical ingredients (“API”) into the EU are changing in 2013. These changes will happen in two stages:

  • From 2 January 2013, all imported API will need to be manufactured in compliance with EU-equivalent standards of good manufacturing practice (“GMP”).  
  • From 2 July 2013, manufacturers of API must obtain written confirmation from the regulatory authorities of the country of manufacture confirming that the manufacturing site is subject to control and enforcement of GMP at least equivalent to that of the EU.

Industry has accused the European Commission of not providing enough guidance on the changes. In response, the Commission recently published further guidance and an updated Q&A document on the changes.

Summary of the Guidance

The main points of the guidance are:

  • Format – There is a template to be used by non-EU regulatory authorities providing the written confirmation.
  • Written confirmation – The confirmation must cover manufacturing of a particular API at a particular site. This is required even if a ‘mutual recognition agreement’ exists between the EU and the country of manufacture of the API.  
  • Import documentation – A copy of the written confirmation must accompany each imported API consignment, however, each consignment will not need its own written confirmation.
  • Approved countries – API which is manufactured in non-EU countries whose rules on GMP are equivalent to those of the EU will be exempt from the new rules. To date, Switzerland, Israel, Australia, Singapore and Brazil have applied for this exemption.  
  • Use of previous inspections – The regulatory authorities of the non-EU country can base confirmation on inspection results from EU authorities or other authorities applying equivalent standards of GMP e.g. US Food and Drug Administration.

Present Status

Many industry players already manufacture APIs in accordance with EU-equivalent GMP and will not be concerned with this aspect of the changes. Industry is, however, fearful that regulatory authorities in certain non-EU countries will be unable or unwilling to comply with the new requirements. This could leave API importers struggling to find compliant sources of products. The European Commission has been in contact with non-EU regulatory authorities to ensure that they understand the new rules. Indian authorities have sought to allay fears by stating that India will be able to implement the new requirements ahead of July 2013. In contrast the Chinese authorities have been less clear on their approach.

The European Commission recently asked EU pharmaceutical trade associations to provide it with information on how their members were preparing for the new rules. The European Commission is currently reviewing the responses and is expected to hold a meeting with these organisations in December to discuss the industry’s preparedness.

Comment

In the meantime, industry should consider:

  • liaising with pharmaceutical industry associations for information on the meeting with the European Commission; and
  • approaching the relevant non-EU regulatory authorities to discuss how they will obtain the necessary compliance certificates as soon as possible.

Manufacturers also need to be checking now with their API suppliers and putting in place any contingency plans.