January 20, 2007

2006: Year in Review
While the preceding year brought one of the most profound changes in the Japanese drug legislation in decades - the enforcement on April 1, 2005 of the amended Pharmaceuticals Affairs Law (PAL), the passed 2006 should be remembered as a year of steady reform implementation.

The key developments in 2006 were related to new product approvals, influx of foreign manufacturers to Japan, and information disclosure.

 Reviews: Product approvals | Foreign manufacturers | Disclosure

Tokyo office

Major developments
Product approvals
Keywords: unapproved, orphan, CNS
The Minister of Health, Labor and Welfare in 2006 granted approval for new drugs in five rounds, as in 2005, however the number of approved products and formulations (including newly approved and amended approvals for manufacturing or import) increased to 90 from 64 last year. Dominant category among the approvals was CNS drugs with both domestically-developed and overseas products. The tendency toward faster introduction of unapproved medicines was further reinforced and some of the designated by the Committee for the Examination of the Use of Unapproved Medicinal Products drugs proceeded to submission. 2006 was also successful for orphan candidates with new designations and approvals.
The speedier approval of some of the orphan products such as Aldurazyme resulted from the efforts of the increasingly vocal patients advocacy groups, another commendable trend.
Foreign manufacturers
Keywords: market share, generics, newcomers Much maligned impenetrability of the Japanese market took several hits in 2006. The influx of foreign manufacturers into 60 billions Japan pharmaceutical market steadily continued as all foreign-capitalized drug makers now held 34% market share. The system permitting registration of Master Files - firstly introduced in the spring of 2005, considerably expanded last year. By December 2006, the overall number of registered Master Files reached 2,293, sponsored by over 600 registrants from nearly 40 countries around the world. Separately, over foreign 700 applicants took advantage from the newly introduced system for accreditation of foreign manufacturers to obtain certificates. The acknowledgment that arguably near 30% of anticancer medicine, otherwise available in the rest of the industrialized world, are not registered - and in some case, even not under development in Japan, led to a swift governmental initiative to accelerate the introduction of those foreign products, possibly best illustrated by the approval in January of Alimta after only 5 months of review by the authorities. Aside from the patented drugs, the landscape of another segment of the Japanese pharmaceutical market - generics, started to change dramatically. Lured by still disproportionally low market share of just 16% for generics in Japan, several of the largest international makers open subsidiaries or established joint ventures encouraged by the much lower than EU and North America market penetration of generics in Japan. 
Information disclosure
Keywords: reviews, proceedings,
Year 2006 was also the fifth anniversary of the enforcement of the Public Access to Information Law (PAIL) in Japan, and the progress - particularly in the field of pharmaceutical affairs has been dramatic compared to the past. Notably, among major contributors to the increased transparency is the Society for Japanese Pharmacopoeia (SJP) with its ever expanding series of information meetings where the very same Government officials and technical experts responsible for reviewing and approval process are most frequent presenters. In spite of the officially recognized understaffing of drugs and medical device reviewing offices of PMDA, the relevant drug approval documents - such as Approval (Evaluation) Review and Summary Basis of Approval (Japanese equivalent) were made publicly available much faster than previous years.

Approval decisions
January 30: MHLW competed changes in PI precautions for all anti-depressants
February 23: PAFSC recommended 6 new products for approval
March 8: PMDA revised clinical trials consultation procedure
March 31: MHLW to require EBM data in pediatric drugs approval
April 3: PAFSC recommended 6 new products for approval
April 20: MHLW approved 32 new products
May 31: MHLW approved 6 new products
June 29: MHLW approved 13 new products
July 27: MHLW approved 32 new products
August 24: First Subcommittee of Drugs recommended 7 new products for approval
August 25: Second Subcommittee of Drugs recommended 6 new products for approval
September 22: Special Committee of Drugs recommended 17 new products for approval
October 18: First Subcommittee of Drugs recommended 3 new products for approval
October 19: Second Subcommittee of Drugs recommended 3 new products for approval
October 20: October round of drug approvals began with 3 new products
November 29-30: The First and Second Subcommittees of Drugs recommended 14 new products for approval
December 25: The Science and Technology Council: the number of examiners of new drug and medical devices approval applications to increase from 2007 and to double by 2009
December 26: PAFSC recommended 25 new products for approval in January 2007

 ...and 2007?

More approvals, increased presence of foreign makers and better news on medical devices

  • January 28: Takeda to ship a new vaccine for the first time in 15 years
  • February 1: Sandoz aims to become top generic maker
  • May 8: MHLW positively comments on Pharma Industry Vision achievements
  • May 12: Teva Pharmaceutical Industries set up a subsidiary in Japan
  • June 8: Diet revised PAL to deregulate sales
  • August 10: Thalidomide submitted for approval
  • September 11: Safety of Crestor confirmed in large PMS
  • October 26: Government not to revise drug prices in April 2007
  • October 31: Aldurazyme approved for MPS I
  • November 7: Survey showed drug firms favored by institutional investors
  • December 14: JPMA annual survey shows two-fold increase of the difference in the length of review and approval process in Japan vs. USA for 2005
  • December 21: Package Insert for Chugai's Rituxan revised: 8 dead of fulminant hepatitis
  • December 29: Drug development consortium formed by 21 drug manufacturers and 14 governmental research institutions

Key meetings

    January 19: The Committee for the Examination of the Use of Unapproved Medicinal Products held its 7th session
    February 17: Current Issues in QA of Medicinal Products meeting
    April 27: The Committee for the Examination of the Use of Unapproved Medicinal Products held its 8th session
    May 19: Introduction to Japanese Pharmacopoeia XV Edition seminar held in Tokyo
    July 26: 14th ICH Immediate Briefing held in Tokyo
    July 28: The Committee for the Examination of the Use of Unapproved Medicinal Products held its 9th session - 5 new products recommended for development in Japan
    September 14: 23rd New Drug Evaluation Division Information Meeting held in Tokyo
    October 17: Current Issues in QA of Medicinal Products Autumn 2006 held in Tokyo
    November 1: MHLW initiates public hearing on drug approval and healthcare needs
    November 17: The Committee for the Examination of the Use of Unapproved Medicinal Products held its 10th session - status of 30 products updated, 3 new products added for monitoring of the domestic development
    December 7: Second meeting of the Study Group for Accelerating Delivery of Safe and Effective Medicinal Products held: in January 2007 the discussion to improve the approval system to enter the decisive phase
    December 21: 15th ICH Immediate Briefing held in Tokyo


Japan Approvals Databases (JAD)
1999 - 2007
(ISSN 1550-3399)

In 2006, the flagship JAD Basic Database was further extended and supplemented with two extended databases of new type: JAD Japan Master Files Database and JAD Orphan Drug Designations Database...more info

Further readings and information

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