DRAP notified the Pharmacovigilance Rules, 2022, for active monitoring of safety of therapeutic goods across the country

The pharmacovigilance Rules, 2022, notified on 22nd April, 2022 , came into effect. This will provide a legal framework to monitor the safety of therapeutic goods throughout their use in the healthcare practice. This legislation details responsibilities of all stakeholders in active supervision of the product’ safety and monitoring, and provides a legal framework to implement and strengthen the pharmacovigilance system across the country. The newly approved rules will have a significant impact to improve pharmacovigilance system in the country, and provides responsibilities to be carried out by the National Pharmacovigilance Centre, Provincial or regional pharmacovigilance Centres, Public Health Programs (PHPs), and as well as, for the products’ registration holders (marketing authorization holders).

The Pharmacovigilance Rules,2022 are aimed at :-

  • Establishing the pharmacovigilance system for the collection and monitoring of Adverse Events, and related data on safety of therapeutic goods;
  • Review and assessment of safety data for effective regulatory actions to ensure the safe use of drugs, vaccines, medical devices, etc.;
  • Encourage reporting of Adverse Events by the Healthcare Professionals, Patients and Consumers of therapeutic goods;
  • Better communication and collaborative working among all stakeholders.

To know more about please navigate to “How DRAP Monitor Safety of Therapeutic Goods“, and “How to Report Adverse Events?”

Amendments in the Medical Devices Rules, 2017 (SRO 1500 (I) 2021)

S.RO.1500(I)/2021.- In exercise of the powers conferred by section 23 of the Drug Regulatory Authority of Pakistan Act,2012 (XXI of 2012), the Drug Regulatory Authority of Pakistan, with approval of the Federal Government, is pleased to direct that the following amendments shall be made in the Medical Devices Rules, 2017, namely:-

 In the aforesaid Rules,-

(a) in rule 6, in sub-rule (l).-

(i) for clause (c), the following shall be substituted, namely;- “(c) the manufacturing shall be conducted under the active supervision of competent technical staff, who shall be in-charge of production, a whole time employee of the manufacturer and having relevant qualification and experience as deemed appropriate by the MDB;”; and

(ii) for clause (e), the following shall be substituted, namely:- “(e) the in-charge of quality control shall be a whole-time employee of the manufacturer and shall possess relevant qualification and experience as deemed appropriate by the MDB;”; and

(b) in rule 63, in sub-rule (3), expression after the words “omit any”, the words “Form or” shall be inserted.