Pakistan: Revised Data Requirements for Contract Manufacturing of Drugs

The Drug Regulatory Authority of Pakistan (DRAP) revised the data requirement needed for the application of extending permission on drug manufacturing contracts. The revision has been notified on 13 June 2023 by DRAP.

The revised requirements were purposedly for simplifying the applicants in submitting Form 5F for their applications and systematize the assessment process without affecting the safety, efficacy, and quality of the applied products.

The data requirement required for the application of human pharmaceutical drugs manufacturing contract are: cover letter, fee, and completed and verified Form 5F (Module 1).

For Form 5F (Module 2-5), the applicants should refer to previous approval of the same formulation and from the same manufacturing site with the conditions:

• Declaring that the adoption of the sources of the drug substances, drug product information, specifications, and container closure are similar. The declaration has to be submitted to DRAP

• For post-registration variation applications, the applicants or registration holder must apply the same for the required Registration board approval

• The previous approval of the applied drug products by the Registration Board can be used as references with a condition that the drug products come from the same manufacturer

DRAP has also agreed to allow multiple strengths drug submissions with only one of the strengths listed on Form 5F. This approval comes with conditions that the drug products must be manufactured from the same source drug substance. Certificate of Analysis must be submitted by the applicants if different lot or batch numbers of the same source of drug substances are being used in developing multiple strength of drug products.

Source: Drug Regulatory Authority of Pakistan (DRAP)

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