Integrating EU and US regulation
Pharmaceutical Technology Europe interviews Sylvia M. Findlay, Programme Leader at Frost & Sullivan. The company has recently released a report entitled Drug Approval Process in Europe An Outlook and believes that integration of the EU and US drug approval process is a necessity.
Q1: The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is working to develop a standard set of regulatory processes for Europe, the US and Japan. Do you know anything about the progress that has been made so far?
The drug regulatory systems in all three regions share the same fundamental concerns for the safety, efficacy, and quality of drug products. The ICH Common Technical Document allows data in the same format to be submitted to drug review authorities in all three ICH regions.
Medical Dictionary for Regulatory Activities (MedDRA) is a new international medical terminology designed to improve the electronic transmission of regulatory information and data worldwide.
Q2: What are the main barriers to the formation of an integrated drug approval process and how do you think these can be overcome?
ICH has made some progress in this area and is working towards an integrated regulatory system.
Q3: Can you provide a brief overview of some of the differences between the EU and US approval processes for drugs and biosimilars?
Q4: And some of the differences regarding parallel trading?
Parallel trading has gained significant weight in the European pharmaceuticals industry and its value is estimated at approximately 2% of the total European pharmaceutical sales. The US drug industry has witnessed parallel trading in the past and it is a very potential country for parallel traders. With the Pharmaceutical Market Access and Drug Safety Act (S.334), parallel trading has been legalized between US and Australia, New Zealand, Canada, the EU, Japan and Switzerland. The US has to keep a close eye on parallel trading to ensure it does not replicate the EU scenario.
Q5: The EU has pioneered the creation of a regulatory pathway for biosimilars. Can you tell us more about this?
Biosimilars are mandated to undergo the centralized procedure for marketing authorization, but the reference product used for the comparability studies should be authorised in the EU and a high standard for quality assessment is demanded by the new legislation. The marketing authorization holder should consider which indication ought to be studied while developing a biosimilar, but the Committee for Human Medicinal Products (CHMP) will provide scientific advice towards biosimilar development. The CHMP has been developing a set of guidelines towards the comparability issues regarding the quality (EMEA/CHMP/49348/05), pre-clinical and clinical features (EMEA/CHMP/42832/05) of the drug.
Q6: What problems stem from the gap between European regulatory authorities and national pricing authorities?
Q7: How likely is it that an integrated transatlantic regulation will be formed?
Q8: How likely is it that an EU-wide synchronized approval process across all member states will be formed?
Q9: Why is globalization vital for the future of the pharma industry?
More information about Frost & Sullivan's Drug Approval Process in Europe An Outlook can be found here.
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