The seven-page proposal, released ahead of Transatlantic Trade and Investment Partnership (TTIP) negotiations between the EU and the US, would create a specific annex in those trade talks on medicinal products. Under the EU proposal, FDA and EMA would further harmonize their respective requirements and procedures for approving new drugs, further remove unnecessary and duplicative preclinical and clinical testing and eliminate duplicative inspections of manufacturing facilities.
In addition, the proposal looks to further EMA and FDA dialogue on scientific matters, which may cover research, development and assessment of different types of drugs, generics, biosimilars and medicinal products of major public health interest, or that address unmet medical needs, including those eligible for accelerated regulatory review. Further collaborations will take place around the development of guidelines, recommendations and initiatives to promote the development of rapid diagnostics, alternative treatments and new antimicrobials as part of efforts to combat anti-microbial resistance.
Certificates of Good Manufacturing Practice (GMP) compliance issued by FDA, EMA or a national EU regulator, demonstrating that the manufacturing facility is compliant, will also be part of the upcoming negotiations. The proposal also seeks to add a new annex on the mutual acceptance of manufacturing inspections.
The proposal also seeks to vastly expand the type of information that may be exchanged between FDA and EMA, including:
- All legislation and guidance documents governing medicinal products, including position papers, notes for guidance and any other guidance documents either in draft, final or released for consultation.
- Information contained in applications for scientific advice, orphan medicine designation, marketing authorization or post-authorization activities of significant public health interest, and applications for agreement of pediatric investigation plans.
- Pharmacovigilance data, particularly “of an urgent nature related to adverse drug reactions, as well as safety concerns arising from periodic safety update reports and post-authorization obligations and commitments.”
- Information on Good Clinical Practices (GCP) inspections and GCP inspection reports.
- Information on Good Manufacturing Practice (GMP) inspections and GMP reports.
- Information on GMP non-compliance, recalls, data integrity and risks of shortages of medicinal products.
The exchange of such information will not publicly disclose confidential information of commercial, technical or scientific nature, including trade secrets not in the public domain, the proposal says. EMA and FDA have previously teamed up to draft pediatric Gaucher disease guidance, to build an active pharmaceutical ingredient database, to share information on Ebola treatments and to share information on generic drugs.
Collaborative Working Group
Also part of the proposal is an idea to create a collaborative working group for regulatory cooperation between the European Commission, with the support of EMA, and FDA and the US Department of Agriculture. The group is expected to support and further develop existing and future bilateral regulatory cooperation between the competent authorities, as well as to establish a joint regulatory cooperation work plan for cooperation in areas of common interest. “The work plan may include areas which are not fully regulated or not addressed at international level and where bilateral cooperation or a common approach on multilateral cooperation and cooperation in relevant international organizations and bodies could advance science and promote harmonization of the requirements, guidelines and procedures applicable to the authorization of medicinal products,” the proposal says.
REFERENCE: RAPS; 24 MAY 2016; Zachary Brennan