Registration and Marketing Authorisation (MA)
What the exam tests
This domain tests whether you can trace a product from dossier to lawful marketing: which authority signs, which documents are mandatory, how the CTD is assembled, and how post-approval changes are handled. Expect questions on 'who approves', 'what is missing from the file' and 'what happens next'.
The legal spine
- The Drugs Act 1976 and the Drugs (Licensing, Registering and Advertising) Rules 1976 remain the operative statute and rules; the DRAP Act 2012 moved their administration to the Drug Regulatory Authority of Pakistan.
- Registration is granted through DRAP's Drug Registration Division, with the Registration Board as the technical forum; appeals go to the Appellate Board.
- No product may be manufactured, imported, sold, stocked or exhibited for sale unless registered. Registration is product- and site-specific.
What a complete dossier contains
A Common Technical Document: Module 1 regional administrative data (labelling, patient information, price application), Module 2 quality/nonclinical/clinical overviews and summaries, Module 3 CMC (composition, specification, validation, stability), Module 4 toxicology, Module 5 clinical or bioequivalence. Imported products add a WHO-scheme Certificate of Pharmaceutical Product, free-sale certificate, GMP certificate and site master file, normally attested or legalised. Stability must match Pakistan's climatic zone: long-term 30 °C/75% RH.
Worked example
An applicant files a generic BCS Class II immediate-release tablet. Because the drug is Class II, a bioequivalence study is expected: fasting, crossover design, with 90% confidence intervals for AUC and Cmax inside 80.00–125.00%. The study itself needs ethics approval and a DRAP clinical-trial authorisation before dosing. Only then do the quality, BE and labelling data go forward for registration.
Traps
Assuming a provincial sale licence authorises manufacture; submitting an expired GMP certificate; offering 25 °C/60% RH stability data; omitting the price application and then wondering why the file stalls.