Amendment of Pharmaceutical Affairs Law (PAL) in 2002

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Chapter: Pharmacovigilance: Pharmacovigilance and Risk Management in Japan

In addition to the legal duty of the health profession-als to report an ADR, many other changes were made in the 2002 amendment of PAL.


AMENDMENT OF PHARMACEUTICAL AFFAIRS LAW (PAL) IN 2002

In addition to the legal duty of the health profession-als to report an ADR, many other changes were made in the 2002 amendment of PAL. The 2002 amend-ment of PAL has important implications concerning the status of pharmacovigilance in Japan from 2002 to the present time and beyond (possibly until around 2010). The 2002 amendment of PAL is character-ized by (1) the enhancement of post-marketing safety measures (detailed in the next section) and (2) the introduction of new regulations to further ensure the safety of biological products. Because strict regulation of biological products was an urgent social require-ment in the late 1990s, the 2002 amendment gave it top priority. In the 1990s it became clear that many hemophiliacs with HIV infection contracted the virus from plasma products prepared in the 1980s. The occurrence of many of these cases might have been prevented by stricter regulation of blood products. Indeed, a senior official in the MHW was arrested in 1996 because of nonfeasance of preventive measures against the spread of the HIV infection. Similarly, many patients suffering from hepatitis C contracted the virus from blood and plasma preparations made around 1980. Many of these cases might also have been prevented by better regulatory measures, includ-ing restriction of the widespread superfluous use of blood and plasma preparations particularly up until the mid-1980s in Japan. In the 2002 PAL amendment, ‘specified biological products’ were defined for some blood and plasma preparations requiring special regu-lations, including long-term record retention covering manufacturing, distribution and administration.

Another important feature of the 2002 PAL amend-ment included (3) the introduction of a marketing authorization holder (MAH) license by which it is no longer required to possess manufacturing facili-ties to market drugs in Japan. Associated with the 2002 PAL amendment, (4) the Pharmaceutical and Medical Device Agency (PMDA) was established in April 2004 under Law of the incorporated adminis-trative agency – Pharmaceutical and Medical Devices Agency enacted in December 2002.

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