Japan Begins Generic Drug Registration Reform

Japan's health regulator, the Pharmaceutical & Medical Safety Bureau (PMSB), has issued a new set of rules for the registration of generic drugs. From the start of this month, manufacturers have been able to receive approved drug master files for their products and submit to mandatory Japanese inspections of overseas manufacturing facilities. Previously, lengthy re-registration was required whenever manufacturers wished to transfer production to another site.

However, some Indian generics firms have complained that the measures do not mark a significant step forward, even though a number of leading companies, such as Ranbaxy, have established Japanese offices or joint ventures.

One significant obstacle still in force is the requirement to conduct full clinical trials for each product prior to registration, even if it has been approved for marketing in the US or Europe. This regulation, which the PMSB justifies on the grounds that Japanese people tend to have differing physical characteristics from much of the Western world's population, has affected market entry strategies.

Many international generics makers tend to partner with local firms for clinical trials and marketing, often subsequently adapting the formulation to meet strict criteria for Japanese consumers. Many generics makers still do not expect Japan's tough generics regulations to fall into line with US and EU norms for at least another three years. Nevertheless, as Japan increasingly looks to generics to contain its drugs bill, it appears that generics makers' interests are gradually beginning to coincide with the government's plans for the sector.