Japan's MHLW Launches Huge Wave of Unapproved Drug Development Requests, Pfizer Tops List with Seven Drugs

Japan's Ministry of Health, Labour and Welfare (MHLW) has issued a large wave of requests for the development of 108 drugs with high medical need but not yet approved in Japan following a recent review meeting. Among the 108 drugs, the MHLW designated the request for development of 91 drugs to some domestic and multinational manufacturers while the other 17 were put in public offer for pharmaceutical companies' development interest. U.S. drug heavyweight Pfizer has seven drugs included in the request list followed by GlaxoSmithKline (GSK, U.K.), Novartis (Switzerland), Japan's Nobel Pharma and Shionogi with each having five drugs listed.

In addition to the 91 drugs with designated manufacturers, the MHLW has also listed 17 drugs for public offer. A full list of the 108 drugs can be found here (in Japanese).

Outlook and Implications

The list of 108 drugs was selected by a panel of the MHLW out of over 300 medicines recommended by doctors and patient groups during its review in last month (see Japan: 28 April 2010: MHLW Panel Selects over 100 Unapproved Drugs for Fast-Track Development). The said drugs have covered a wide range of indications, among which the expansion of paediatric indications, oncology drugs and rare disease treatments have taken up a significant part. The move is a highlight of the MHLW's determination to encourage the speedy development and commercialisation of drugs already approved in the overseas market but not yet cleared in Japan. The authority is aiming to shorten the country's infamous drug lag, which has seen drugs sometimes approved in Japan years later than in other developed markets such as the United States and Europe. In addition, the drugs in concern are also expected to be available faster in Japan through this scheme in order to fulfil unmet medical needs in the market.

The pharmaceutical companies designated for the development and marketing of the said drugs are therefore standing in a good position as they will receive potential benefits including the fast-track regulatory review process as well as a premium if they are included in the country's national health insurance (NHI) listing. Drug makers like Pfizer, GSK and Novartis will therefore see a promising prospect for their drugs in terms of entering into Japan, expanding their indications or patient groups. However, the encouragement has not come without restrictions as the authorities are mulling the imposition of conditions on the grant of premium. The conditions include designated timelines for clinical study advancement and regulatory filing in order to ensure the accelerated development and filing of the unapproved drugs (see Japan: 21 December 2009: MHLW Proposes Relaxation on Average Overseas Prices Calculation, Biosimilars to Receive 10% Premium).