Pakistan – Pakistan Posts Draft Accelerated Approval Guidelines in Flurry of Activity

The Drug Regulatory Authority of Pakistan (DRAP) has published draft guidance on its priority review and accelerated approval processes. DRAP released the guidelines alongside a clutch of other guidance documents covering topics including pharmacovigilance and post-registration variations.

Like many other regulators, DRAP is open to offering certain drugs a streamlined path to market to ensure patients get timely access to particularly important therapeutic interventions.

“DRAP recognizes that there are circumstances in which standard requirement and procedure for registration / market authorization may be challenging to fulfill and there is an unmet need of such drugs in the country. In such situations, DRAP supports the availability through registration of drug products that address the unmet medical needs in special situations,” the agency wrote…