Pakistan Releases Draft Accelerated Drug Approval Guidelines
Pakistan Releases Draft Accelerated Drug Approval Guidelines
From the desk of DRAP- 05 November 2019
The Drug Regulatory Authority of Pakistan (DRAP) has published draft guidance on its priority review and accelerated approval processes alongside other guidance documents covering pharmacovigilance and post-registration variations.
The DRAP has created guidelines that stipulate two pathways with similar objectives. One pathway provides for priority…
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