The new article describes in detail the approach to be applied when it comes to content development.
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 representative 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. The scope of the guidance covers, inter alia, the aspects related to the content of reporting in line with the general reporting goals explained in the previous article.
Initial Indication
According to the guidance, in order to ensure smooth operation and data integrity while using the Industry e-Reporting System, the following measures are advised for all the parties involved:
- Power Backup: Use equipment with reliable electricity backup to prevent data loss during power outages.
- Internet Stability: Maintain a high-speed and stable internet connection for uninterrupted access.
- Browser Compatibility: Use updated versions of Chrome, Firefox, or Microsoft Edge for optimal system performance.
- Account Security: Safeguard account credentials by not sharing login details and ensure session security by logging out when the platform is not in use.
- Compliance: Adhere to the “Terms and Conditions of Use” outlined in Annex A of the document.
- Mitigating Data Loss: Be aware that internet or power interruptions can result in unsaved data being lost if reports are not submitted in time.
Application for User Accounts
As further described by the authority, the process for acquiring user accounts requires the following steps:
- Ensure that the Pharmacovigilance System and the details of the Qualified Person Responsible for Pharmacovigilance (QPPV) or Local Safety Officer (LSO) are up to date in the NPC-DRAP database. Communication with these representatives will occur exclusively via email.
- Submit a request for user accounts via email along with a completed proforma provided by NPC-DRAP.
- Two user accounts will be issued for each registration holder, assigned by the Director, Pharmacy Services Division/Head of NPC-DRAP.
- Ensure that email addresses provided for account setup are corporate or institutional.
- At the last stage the applicant should provide the key information, including, inter alia, the details about the company and the license.
Upon first login, the applicant will be able to set up login credentials. The authority additionally emphasizes they are stored properly in a safe way, preventing third parties from having access to them in line with the general information security practices.
WHO-Drug License Activation and Management
The WHODrug Global Dictionary facilitates systematic drug coding, enabling traceability, standardized data analysis, and risk communication.
To activate and manage the WHODrug license, the applicant should:
- Navigate to the “Manage Licenses” section in the system menu.
- Enter their WHODrug license number and save the information.
- A validation message will confirm successful activation.
Important Notes:
- WHODrug coding requires an active license for use in manual uploads and XML file submissions.
- Users must renew their MedDRA license to avoid interruptions in coding functionalities. Expired licenses will block encoding fields in the system.
- Utilize WHODrug Insight for extended searches and technical guidance.
Specific Indications for Reporting
The following rules apply when submitting reports through the Industry e-Reporting System:
- New Cases Only: The applicants should submit only new Individual Case Safety Reports (ICSRs) and their follow-ups through the new system. Previous cases should be submitted via email or in hard copy and must continue to be managed through the original channels.
- Nil Reporting Exclusion: The system does not support the submission of monthly/quarterly nil reports. Registration holders should continue using the existing mechanism for such submissions.
Conclusion
In summary, the present DRAP guidance describes a step-by-step procedure to be followed when creating an account to be used for e-reporting, emphasizing the key aspects the applicants should pay attention to.
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