Pharmaceutical Regulatory Affairs and IPR

Biography

Biography: Mohammed R Khan

Abstract

Although the Thalidomide tragedy of the early sixties is regarded instrumental in the amendment to the US FD&C Act of 1938, and first appearance of the term Good Manufacturing Practice in 1962, but the GMPs were conceptually evolving for quite some time in the US as well as in Canada. Noticeable amongst such efforts was a paper on “Quality Control” by Dr Frank Taylor published in the journal of the American Pharmaceutical Association in March 1947, but the first modern code that could be regarded as the first set of GMPs as we know them today, were the 1957 QUAD (Quality Assurance of Drugs) regulations dealing with the Manufacture, Control and Distribution of Drugs issued by the Canadian Specifications Board of the Supply and Services Department in order to ensure that drug products supplied to the Canadian Military were of the specified quality. Likewise, the term “Quality Assurance” was also first introduced to the Regulatory lexicon by Canada, which has since gained unparalleled international recognition. The success of the Canadian QUAD regulations led to accelerated issuance of the GMPs by Regulatory Agencies, with the US FDA issuing the first version in 1963 which underwent massive revision in 1973 and reissued in 1976. While the British drafted their GMPs in 1968 and issued those in 1973, more than 25 countries followed suit by the early 1980s. In the forefront are the US, Canadian, British, Japanese, WHO, PIC/S and the ICH Guidelines, and it is not uncommon for most countries to revise their GMPs usually every five years in order to maintain the currency status. The single exception has been the US FDA with the first revision in 2015 since issuance in 1976! Conversely, Canadian GMPs have undergone eight revisions thus far, and are harmonized with GMP standards from other countries and with those of WHO, PIC/S and ICH and take into account the implementation of the current MRA.