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Drug Regulatory Authority of Pakistan

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Home > News & Updates > Regulatory Updates > Clinical Trials > SRO 685(I)/2023 dated 09-06-2023: Amendments in the Bio Study Rules, 2017

SRO 685(I)/2023 dated 09-06-2023: Amendments in the Bio Study Rules, 2017

Asad Ullah Clinical Trials, SROs June 14, 2023June 16, 2023

The Drug Regulatory Authority of Pakistan, with the Federal Government’s approval, has made amendments to the Bio-Study Rule 2017. Through this amendments, the Application Form (Form-IIA) for BA/BE Studies has been revised to rationalize the requirement for submission of the reference product’s Certificate of Pharmaceutical Products (CoPP). The Notification issued in this regard is as under:-

S.R.O.-685-Form-IIADownload

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  • ← SRO 678(I)/2023 Amendments in the Drug Pricing Policy-2018.
  • Notification: Application on Form-5F (CTD) for Extension in the Contract Manufacturing Permission of Drugs. →
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Drug Regulatory Authority of Pakistan

  • Islamabad | Karachi | Lahore | Peshawar | Quetta
  • Phone: 0800-03727 (Mon to Fri 08:30AM to 04:30PM)
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