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
- Scientific collaboration
- Guidelines, format harmonisation and electronic submission
In the field of GMP compliance, the parties agreed the
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
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
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.