Pharmaceutical Affairs Law (PAL) Japanese Good Manufacturing Practice (JGMP) transition period ends 1 April 2007
March 23, 2007-- When Pharmaceutical Affairs Law (PAL) became effective on 1 April 2005, some of the provisions related to productions controls (so called Japanese Good Manufacturing Practice (JGMP) or Ministerial Ordinance 169) were excluded for a period of 2 years. This includes requirements such as management responsibility, risk management in production, design controls (if applicable), criteria for suppliers, process validation and analysis of data. Manufacturers using ISO 13485:2003 will already have most of these controls in place. However, it is possible that earlier JGMP audit reports showing the exclusions could inadvertently be used in new applications. From April 1, care should be taken that any new applications for product certification or approval include JGMP documentation covering all applicable requirements for the device.
In the past 14 months, the Ministry of Health, Labor and Welfare (MHLW) has also approved a further 24 "essential principle checklists", effectively increasing the number devices that can be handled by third party agencies from 772 to 815. Although the third party agencies such as UL Japan are in principle intended to handle Class II devices, only those with designated controls as defined in these checklists are eligible for third party review. The increasing availability of these checklists is important for manufacturers in gaining smoother access to the Japanese market.
Peter Selvey, Underwriters Laboratories Japan.