Pharmaceutical Executive Europe - September 2008 - (Page 23) Regulatory Affairs and FDA should, under this agreement, pilot joint inspections of companies manufacturing finished medicinal products in the EU and the US, as well as companies producing APIs in other countries. According to an EC spokesman, these inspections should start at the end of the year, but preliminary discussions have already been initiated to determine the pharmaceutical manufacturing facilities where they are needed. On both sides of the Atlantic, it is stressed that doubling up on inspections should ensure high standards are maintained and reassure companies that they are dealing with a united regulatory front. The programme requires that FDA and EMEA share inspection schedules, results and information on inspected manufacturing facilities. It is also expected that this cooperation will allow the regulatory bodies to better identify sites making APIs in third countries and ensure that these facilities are adhering to GMPs. This increased vigilance is intended to lead to higher regulatory standards and increased supply chain security. The harmonisation of administrative procedures and the safety of the medicinal product are the prime objectives of the new joint inspection programme. By pooling their resources, the EU and the US will inspect more sites and increase pressure on pharmaceutical companies, both at home and abroad, that do not respect GMPs. In practice, there are doubts about the efficiency of a programme that focuses on ad hoc exchange of non-emergency information… This is very good news for those pharmaceutical companies that do respect GMPs. A single inspection by a joint EU–US team could provide simpler, quicker and more effective access to the US and European markets. Problems in parallel This new regulatory development was first discussed in an administrative simplification workshop, held in Brussels (Belgium) in November 2007, as part of the ongoing confidentiality arrangements between the EU and the US. The sharing of information on inspection outcomes was already part of the confidentiality arrangements and is currently done on an ad hoc basis. The types of information covered by the arrangements include legal and regulatory issues, scientific advice, orphan drug designation, inspection reports, marketing authorisation procedures and post-marketing surveillance. The implementation plan allows for regular exchange of GMP, GCP and pharmacovigilance inspection information. As far as the new inspections initiative is concerned, the EC wants to look at how these exchanges can be expanded upon. In practice, however, there are doubts regarding the real efficiency of a programme that focuses on ad hoc exchange of non-emergency information. Indeed, too many differences already hinder the collaboration between the two regulatory bodies and these issues have been highlighted with the setback of another similar EU–US initiative that did not achieve the anticipated results: the Parallel Scientific Advice (PSA) Programme. The PSA Programme began in January 2005. It sought to better co-ordinate regulatory approval of medicinal products by allowing companies to seek parallel scientific advice on testing their new medicinal products (that is, new human drugs and biologics) from both EMEA and FDA simultaneously. Claiming, perhaps prematurely, the success of this pilot programme, it was decided in March 2006 to extend the pilot phase, and to intensify transatlantic cooperation in the area of medicinal products, with particular focus on vaccines (including preparedness for influenza pandemic), medicines for children, medicines for rare diseases, oncology and pharmacogenomics. The programme was expected to: increase dialogue between agencies and sponsors from the beginning of the product life cycle; optimise product development by avoiding unnecessary testing replication or unnecessary diverse testing methodologies; allow for additional critical issues to be identified and shared by both agencies; and streamline development and facilitate access, for example, for orphan drugs and products eligible for accelerated review. However, in practice, uptake was disappointing and experience varied 25 Last Words The month’s key events from the industry’s mouth. 4 News A round-up of the last four weeks in pharma. 7 Calendar Upcoming conferences and exhibitions. 10 Brussels Report Competition between the bioindustry associations.
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