|Enhancement in validity period of GMP certificate from 1 year to 3 years for manufacturers of medical devices|
|Ticker||Validity of GMP Certificate Extended to 3 Years|
|Reform Description||Before: DRAP extended the Good Manufacturing Practices (GMP) certification only for one year which required renewal on expiry and resulting compliance.
After: To avoid recurring compliance and associated hassle the GMP certification has been extended to a period of 03 years instead of 01 year.
|Beneficiaries||All healthcare businesses|
|Jurisdiction/ Location||Federal (Entire Pakistan)|
|Department||Drug Regulatory Authority of Pakistan (DRAP)|
|Date of Implementation||***|
|Details||Difficulty||The validity period of Good Manufacturing Practices (GMP) certification by DRAP was only 01 year which required renewal on lapse of every year leading to the associated procedural compliance burden and hassle.|
|Analysis||After research and analyzing the practices adopted by various countries with Stringent Regulatory Authority it was felt that Good Manufacturing Practices (GMP) certification may be extended for a period of 03 years.|
|Solution||Drug Regulatory Authority of Pakistan (DRAP) has notified that the Good Manufacturing Practices (GMP) certification which was earlier valid for a period of only 01 year no stands valid for a period of 03 years.|
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