The article provides a general overview of the electronic reporting requirements in Pakistan.
Table of content
The Drug Regulatory Authority of Pakistan (DRAP), a country’s regulating agency responsible for healthcare products, including medical devices, has published a guidance document dedicated to e-reporting requirements to be taken into consideration by the parties involved in operations with healthcare products allowed for marketing and use in the country. The document provides an overview of the applicable regulatory framework, as well as additional clarifications and recommendations industry representatives should follow in order to ensure compliance.
At the same time, the authority reserves the right to make changes to the document and provisions thereof, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation. In particular, this document provides comprehensive guidance for registration holders of therapeutic goods on creating accounts and submitting reports via the industry e-reporting system to the National Pharmacovigilance Centre (NPC).
The system aims to streamline reporting processes for Adverse Events (AEs), Adverse Drug Reactions (ADRs), and Adverse Events Following Immunization (AEFI).
Regulatory Background
Under the applicable legislation, registration holders are key stakeholders in Pakistan’s pharmacovigilance framework. According to the Pharmacovigilance Rules, 2022, they are legally mandated to gather, evaluate, and report AEs, ADRs, and AEFI.
Previously, reports could be submitted through:
- Hard copy (CIOMS form) mailed to the NPC.
- E2B XML files sent via email.
- Nil reports (monthly/quarterly) sent in hard copy to the official address.
To modernize and simplify this process, NPC-DRAP, in collaboration with the Uppsala Monitoring Centre (UMC), has launched the Industry e-Reporting System.
This system includes:
- A manual data entry module replacing the old CIOMS hard format.
- An E2B upload module substituting email-based E2B submissions.
This manual serves as a step-by-step guide for registration holders to understand and operate the new system effectively.
The document also provides a list of acronyms, such as AE (Adverse Event), ADR (Adverse Drug Reaction), and NPC (National Pharmacovigilance Centre), in order to help with ensuring clarity and consistent terminology throughout the manual. It includes widely recognized terms from international pharmacovigilance bodies like the WHO, ICH, and UMC.
Pharmacovigilance is defined by the WHO as the science of detecting, assessing, understanding, and preventing adverse effects or any drug-related issues. Its ultimate goal is to enhance the safety and rational use of medicines, benefiting both patient care and public health.
The global pharmacovigilance system emerged after the Thalidomide tragedy in the late 1950s and early 1960s, which highlighted the risks associated with medicine use during pregnancy. This tragedy led to severe deformities in infants and catalyzed the creation of reporting systems like the US FDA’s Form-3500 and the UK’s Yellow Card Scheme.
The WHO responded in 1968 by launching the Programme for International Drug Monitoring (PIDM), initially comprising 10 member countries. Operational activities were assigned to the UMC in 1978, with WHO overseeing the program administratively. Today, PIDM has 157 full members and 23 associate members.
Pakistan’s Progress in Pharmacovigilance
Pakistan joined PIDM as an associate member in 1994 and achieved full membership in 2018, becoming the 134th full member. After the enactment of the DRAP Act, 2012, the Division of Pharmacy Services was authorized to oversee pharmacovigilance activities. In 2017, the National Pharmacovigilance Centre (NPC) was established to coordinate pharmacovigilance efforts both domestically and internationally.
To support stakeholders, NPC has developed tools and guidelines for:
- Patients
- Healthcare professionals
- Registration holders
- Public health programs
As it was mentioned before, previous reporting channels included:
- Hard format submissions via CIOMS forms.
- E2B XML submissions via email.
- Nil report submissions in hard copy.
Collaborating with the UMC, NPC-DRAP introduced the Industry e-Reporting System, already been piloted successfully in countries like Mexico. Registration holders can now report ADRs/ICSRs using:
- Manual data entry modules for structured input.
- E2B upload modules for database-integrated submissions.
Key Features of Industry e-Reporting:
- Compatibility with ICH-E2B (R3) standards.
- Use of structured fields over free text for consistency.
- Integration of MedDRA and WHODrug dictionaries for standardized terminology.
- Attachment of supplementary information in PDF format.
- Instant submission of reports to NPC.
- Follow-up via editable XML files for previously submitted cases.
- Downloadable acknowledgment files in XML format.
NPC emphasizes the use of MedDRA and WHODrug for medical coding, ensuring precise and standardized data reporting. Future updates will mandate their use for all submissions.
Goals
As explained by the authority, the primary goals of the document include:
- Guiding registration holders in submitting applications to access the e-reporting system.
- Providing instructions for first-time login and password creation.
- Explaining the XML file upload process for holders with E2B-enabled databases.
- Offering detailed steps for completing the manual data entry module, ensuring comprehensive and high-quality reporting.
Conclusion
In summary, the present guidance describes the way registration holders can ensure effective compliance with pharmacovigilance responsibilities while contributing to improved drug safety in Pakistan.
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