Joint Inspections and Further Cooperation between EMEA and FDA Announced

GMP News
30 July 2008
 

Joint Inspections and Further Cooperation between EMEA and FDA Announced

  
As a result of a meeting held under the auspices of the Transatlantic Economic Council, a cooperation at the level of administrative practices and guidelines was agreed as already reported in our GMP News. Now more details about the concrete projects have been published. The new cooperation covers four different areas:
- Quality and inspection
- Pharmacovigilance
- Scientific collaboration
- Guidelines, format harmonisation and electronic submission

In the field of GMP compliance, the parties agreed the following projects:

Collaboration on inspections

The Commission/EMEA and the FDA will pilot joint inspections of companies manufacturing pharmaceuticals in the US and in the EU and of companies manufacturing active pharmaceutical ingredients in third countries.

Collaboration on third-country inspections

The Commission/EMEA and the FDA will pilot the exchange of inspection schedules, results, and information on inspected manufacturing sites in order to attain more GMP inspection coverage collectively and to better identify manufacturing sites producing active pharmaceutical ingredients in third countries.

Dedicated facilities for high-risk products

The Commission/EMEA and the FDA will step up collaboration to determine to what extent dedicated production facilities are necessary for certain pharmaceuticals taking into account a risk-based approach. Subsequently, it is expected that a revised EU guideline will be published for public consultation in the first quarter of 2009. FDA is also in the process of clarifying this issue through proposing amendments to existing regulations and draft guidances that are in the process for issuance. (Notice: Containment technologies are currently intensively discussed e.g. at the ECA Conference in Vienna.)


Combating counterfeit medicines

In addition to the collaborative work with the WHO IMPACT initiative, the Commission and FDA will exchange information on future requirements for track-and-trace and authentication systems. Commission/EMEA and FDA will exchange information on specific cases of counterfeiting. (Notice: The different counterfeit initiatives can be found here)

Exchange of information on herbal medicines

The EMEA Committee on Herbal Medicinal Products is to provide draft and final monographs to FDA.

Advanced Therapy Medicinal Products

Under the EC/EMEA/FDA confidentiality arrangements, by the end of 2008, a "cluster" on Advanced Therapy Medicinal Products is intended to be established. The cluster is to strive for scientific excellence, harmonisation of terminology for new technologies and to make recommendations for transatlantic convergence in the administration of regulations for these medicinal products. (ECA has set up a Working Group on Advanced Therapies.)


The FDA and the EU/EMEA recognize with these projects that many of the recent problems did not occur because of a lack of legislation but due to a lack of supervision and enforcement, especially in third countries like China and India. In a separate announcement FDA also said that, in addition to an office in China, it is likely to set up an office for inspections in India.

Source:
http://www.emea.europa.eu/

  

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