Regulatory Developments In recent years, the business climate for European companies operating in Japan has been difficult. The Government has been trying to reinforce consumer protection, which should have been consistent with the promotion of consumer welfare and better access to beneficial new products. Instead, the effort has merely increased bureaucracy. Thus the Government commitment, made in 1995 and reconfirmed every year since, to approve new products within 12 months of the initial application is still rarely achieved. The creation of the Food Safety Commission (FSC) in July 2003 has added further regulation resulting in a growing backlog of products awaiting approval. Equally, revisions to the Pharmaceutical Affairs Law (PAL) introduced in April 2005 have imposed additional certification and compliance requirements, when faster and less costly approaches would have achieved the same results. A benchmark study conducted by the International Federation of Animal Health suggests that the application process for product approvals in Japan lacks speed, predictability and quality. Moreover, in spite of global trends to streamline approval processes, Japan-specific data still have to be added to dossiers for new product applications, at times without any obvious scientific justification. If these conditions persist, international animal health companies will be increasingly likely to stop developing products for the Japanese market. Reduced requirements in the area of batch-release toxicity testing for feed-grade antibiotic products have shown how administrative burdens can be reduced without compromising animal or consumer welfare. The same is true for the elimination of the national assay for most in-vitro diagnostics in August 2006. Further government action is now urgently needed to develop a more appropriate risk-based approach that will eliminate unnecessary steps throughout the product approval and post-approval processes. Given the expected implementation of a seed-lot system and an accelerating global trend towards self-regulation to ensure product conformance under the Good Manufacturing Practice (GMP) regime, the EBC encourages the Japanese government to continue shifting from the use of the national assay to in-house testing for veterinary biological products. Prospects for EU-Japan Economic Integration Introduction of innovative European animal health products into Japan such as veterinary pharmaceutical products, veterinary vaccines and feed additives is essential to enhancing animal health and public health for companion animals and food animals. Japan is one of the largest animal health products markets and therefore of crucial importance to European manufacturers. However, the current regulatory regime lacks transparency, and arduous administrative processes obstruct the introduction of products that have already been accepted in the EU, into the Japanese market. Priorities
Key Issues and Recommendations ■ Product approvals Yearly status report: regress. Products already approved in the EU have to undergo further rigorous controls and tests before being accepted in Japan although reasons related to safety remain obscure. The Ministry of Agriculture, Forestry and Fisheries (MAFF) has set a standard administrative review process of 12 months, but this target is rarely met. Delays derive from the long time allowed to elapse between the submission of a dossier and the so-called "hearing" at MAFF; the slowness of the review process carried out by the Food Safety Commission; and finally from excessive time in issuing notification after the Executive Committee (Yakuji-Bunkakai) has approved the product. The review of registration dossiers has been transferred from MAFF headquarters to the National Veterinary Assay Laboratory with the aim of speeding up and improving efficiency of the process. The result has been an increased regulatory burden and even longer review periods. The administrative procedures need to be streamlined and accelerated. Moreover, unnecessary and scientifically unjustified requirements should be eliminated. MAFF should use all possible means to accelerate administrative processes so that reviews are completed within 12 months, especially for products that do not need a review by the FSC. Recommendation:
■ National assay of vaccines Yearly status report: some progress. The EBC commends the MAFF initiative to introduce the seed-lot system and eliminate the current batch release requirement based on national assays for animal vaccines. The EBC, however, is concerned about the new and unique requirements for a vaccine to be eligible for the seed-lot system, - such as the requirement for an immunogenicity test - which are not in line with the international practice of the seed-lot system. These unique requirements are expected to increase the burden of European vaccine manufacturers and reduce the value and usefulness of the new seed-lot system. Given the expected implementation of a seed-lot system and an accelerating global trend towards self-regulation to ensure product conformance under the GMP regime, the EBC encourages the Japanese government to continue shifting from the use of the national assay to in-house testing for veterinary biological products. Recommendation:
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