Post-marketing surveillance PMS

The need for monitoring long-term followup in post-marketing surveillance (PMS) and safety assessment of marketed medicines studies to determine effects of the drug on physical functions and development, such as bone maturation, growth and sexual development. 

Member companies shall properly recognise the objectives of post-marketing surveillance (PMS), i.e. the establishment of the appropriate usage of marketed pharmaceuticals, and shall conduct such PMS activities on a scientific basis, in strict compliance with laws, regulations and self-regulations. These activities shall not be misused as a means of promotion. 

Post-marketing surveillance (PMS) Safety-related activity after a product is marketed. This process includes but is not limited to spontaneous ADR reports. Pharmacovigilance activities start before a product is marketed after marketing this term may be regarded as synonymous with pharmacovigilance and, nowadays, it is less frequently used (see p. 33). 

Conduct of Post-marketing Surveillance study (PMS) is a regulatory stipulation. Usually the protocol and centres need to have an approval of the DCGI before initiation of the PMS study. 

GPMSP standards were enforced in April 1994 after revision of the text published in May 1993. It became a law in 1997, and was further revised in 2000, to add the Early Post-Marketing Surveillance , applying to new drug in the first six months of marketing. These standards specify the rules to be observed by the manufacturer in order to ensure the reliability of the PMS data, mainly the following ... 

The Good Post-marketing Surveillance Practice (GPMSP). The postmarketing surveillance (PMS) system is a well established system in Japan for collecting safety data in order to prepare the documentation requested for re-examination which will be described in the section on Postapproval Activities, below. 

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