The roadmap for integration of the Drug Regulatory Authority of Pakistan (DRAP) with Pakistan Single Window has been agreed between the two entities.
The development came in a meeting between CEO Pakistan Single Window (PSW) Aftab Haidar and CEO Drug Regulatory Authority of Pakistan (DRAP) Asim Rauf. The meeting was also attended by PSW and DRAP officials collaborating on the program.
DRAP’s integration with PSW will enable the electronic submission, processing and issuance of licenses, no-objection certificates (NOCs), and other certificates, as prescribed for import, export or international transit of specified products falling under DRAP’s regulatory jurisdiction.
PSW will also extend the facility of electronic registration of importers, imported products (drugs, medical devices, health and over-the-counter products), and premises to provide end-to-end integration of all DRAP-related services on cross-border trade to users. Under the initiative, extensive Business Process Reengineering (BPR) of DRAP’s cross-border trade-related processes was carried out resulting in completing BPR of 31 processes, and digitization of 56 paper-based documents with the facility to scan and upload additional documents as required on a case-to-case basis.
During the meeting, the two sides discussed the ongoing initiatives for DRAP’s automation and agreed on the roadmap for DRAP’s integration based on the Business Requirement Specification (BRS) document jointly developed by DRAP and PSW teams and duly approved by the Ministry of National Health Services, Regulation and Coordination Islamabad last year.
Commenting on the development, CEO PSW Aftab Haider stated “DRAP is a high priority trade regulator for PSW and we appreciate the leadership role and ownership that DRAP has demonstrated in spearheading this critical initiative.”
Under the PSW Initiative, DRAP will get better visibility of all imports and exports through an exchange of information and data through the PSW platform. DRAP’s control measures will be further strengthened by the implementation of the Integrated Risk Management System based on risk rules defined by the department.
CEO DRAP Asim Rauf appreciated PSW’s efforts and shared his vision to automate DRAP’s business processes. He informed that DRAP has taken several initiatives to automate its processes such as medical devices online system for establishment license and product registration, online software for clinical trials, online fee challan system and online software of import and export application submission and issuance. He emphasized the need for developing a joint strategy for the digitization of the public sector.
“For us, the most important feature of DRAP’s integration with the PSW is facilitation to DRAP’s stakeholders in the import and export of pharmaceutical raw materials, products, and devices. We are happy to see a system that will be operated and maintained professionally on a sustainable basis,” he said.
DRAP was established in 2012, enacted under the DRAP Act, 2012 and comes under the jurisdiction of the Ministry of National Health Service, Regulation & Coordination Islamabad. The Authority is mandated for effective coordination and enforcement of the Drugs Act, 1976 to regulate the manufacture, import, export, storage, distribution and sale of therapeutic goods in the country. The DRAP Chief Executive Officer (CEO) is the head of the authority.
The PSW is an electronic platform that allows its users to conduct cross-border trade and all ancillary activities through a single, online portal. The PSW will allow parties involved in trade and transport to lodge standardized information and documents at a single-entry point for all import, export, and transit-related regulatory requirements.
Pakistan is committed to implementing the PSW by June 2022 under World Trade Organization’s Trade Facilitation Agreement. The program is being implemented in phases with Phase 1 scheduled for inauguration by the Prime Minister in March 2022.
