N recent years, the Drug Regulatory Authority of Pakistan (Drap) has undertaken a significant transformation, evolving into a more modern, transparent and globally aligned regulatory body.
These reforms are strengthening Pakistan’s healthcare system while enabling the pharmaceutical sector to expand its global footprint.
From the perspective of the research-based pharmaceutical industry, Drap’s progress reflects a clear commitment to fostering quality, innovation and patient safety in line with international best practices.
Today, Drap stands at an important inflection point, driven by regulatory modernisation and digital advancement through collaborative engagement with both local and international stakeholders.
Advancing towards WHO Maturity Level 3 A cornerstone of Drap’s progress is its ongoing advancement towards achieving the World Health Organisation’s (WHO) Global Benchmarking Tool (GBT) Maturity Level 3. This designation represents a stable, well-functioning regulatory system aligned with global standards.
This ambition is both timely and strategic.
Achieving Maturity Level 3 will enhance Pakistan’s credibility as a reliable pharmaceutical market, strengthen international confidence and facilitate greater export potential for locally manufactured products.
The journey has been supported by a series of structured capacity-building initiatives, technical workshops and knowledge-sharing engagements. These have brought together global experts, including WHO specialists and regulators from mature authorities such as Saudi Arabia, enabling practical exchange of experience on reliance pathways, good review practices and benchmarking requirements.
Importantly, multinational pharmaceutical companies have played a constructive role in this process through technical collaboration, contributing to the upskilling of Drap’s human resource base and supporting the development of a more globally integrated regulatory ecosystem.
Strengthening regulatory frameworks and quality systems Drap’s reform agenda has focused on align-ing Pakistan’s regulatory systems with internationally recognised standards. A key milestone has been the adoption of Pharmaceutical Inspection Co-operation Scheme (PIC/S) Good Manufacturing Practice (GMP) guidelines.
This transition marks a decisive shift towards globally harmonised quality standards, ensuring that medicines produced in Pakistan meet stringent safety and efficacy requirements.
It also enhances the competitiveness of the local industry by enabling compliance with export market expectations.
In parallel, Drap has strengthened regulatory oversight through the implementation of bioavailability and bioequivalence (BA/BE) requirements.
These measures are critical for ensuring therapeutic equivalence of generic medicines and reinforcing confidence in the quality of locally manufactured products.
Collectively, these reforms reflect a move towards a science-based, quality-driven regulatory approach that prioritises patient outcomes while supporting industry growth.
Digital transformation and operational efficiency Drap’s adoption of digital technologies has been a defining feature of its recent progress.
Through the implementation of e-governance platforms including e-offices, online registration systems and digitallicensingmechanisms, the authority has significantly improved efficiency and transparency.
These advancements have streamlined regulatory processes, reduced administrative bottlenecks to accelerate approval timelines. Processes that historically required extended timeframes are now managed with greater speed and predictability, enabling industry stakeholders to respond more effectively to market needs.
Faster issuance of regulatory certifications and more efficient export-related processes have further strengthened Pakistan’s position in international markets. At the same time, these improvements directly support patient access by facilitating the timely availability of essential medicines.
Supporting the reliance model Member companies of the Pharma Bureauconducted workshops with Drap where their global regulatory colleagues shared best practice models regarding the Reliance Pathway.
Drap officials have also shown their willingness to participate in an international Post Approval Change (PAC) reliance pilot supported by the EMA and WHO.
This shows their willingness to support global regulatory convergence and reliance, which will ultimately help with the review post-approval dossiers while considering the reliance model.
Enhancing supply chain integrity through Track & Trace Ensuring the safety and integrity of the pharmaceutical supply chain remains central to Drap’s mandate. The implementation of 2D barcoding and Track & Trace systems represents a critical step in this direction.
Through structured technical engagements and stakeholder collaboration, Drap has advanced its capabilities in serialisation, supply chain visibility and anti-counterfeiting strategies.
These efforts align with global best practices and are instrumental in building a comprehensive pharmaceutical traceability system.
The adoption of GS1-compliant 2D Data Matrix barcoding enables end-to-end product tracking, significantly strengthening safeguards against falsified or substandard medicines. For the industry, this represents both a compliance milestone and a shared commitment to patient safety.
Advancing pharmacovigilance and ADR awareness Drap’s growing focus on pharmacovigilance is another important dimension of its progress.
Strengthening systems for monitoring medicine safety and promoting timely reporting of adverse drug reactions (ADRs) are essential to protecting public health.
In this context, the pharmaceutical industry, through Pharma Bureau and its member companies, has collaborated closely with Drap to support ADR awareness initiatives.
A notable contribution has been the development of a public awareness video designed toeducate healthcare professionals and the broader community on the importance of ADR reporting.
This initiative reinforces the principle that medicine safety is a shared responsibility across regulators, healthcare providers and industrystakeholders.
The video, shared with Drap for wider dissemination, has been utilised in national campaigns such as Med Safety Week to maximise outreach and awareness.
Such collaborative efforts play a vital role in strengthening pharmacovigilance systems, enabling more informed regulatory decision-making, and ultimately enhancing patient safety outcomes.
A collaborative way forward A defining feature of Drap’s evolution has been its emphasis on collaboration with sustained engagement across local and multinational industry partners as well as international organisations.
This has helped ensure that reforms are both practical in implementation and aligned with global standards.
The pharmaceutical industry continues to support this progress through compliance, investment in quality systems and knowledge-sharing initiatives, reinforcing a partnership-driven approach that will remain critical as Pakistan advances towards WHO Maturity Level 3 and beyond.
These collective efforts have significantly strengthened Pakistan’s healthcare regulatory landscape.
Drap’s focus on quality standards, digital innovation, pharmacovigilance and global alignment reflects a consistent commitment to excellence. As a result, the sector is becoming more efficient, competitive and internationally integrated.
The impact is increasingly visible: a stronger regulatory environment is enabling industry growth while improving patient outcomes through greater access to safe, effective and high-quality medicines.
As this trajectory continues, Drap’s leadership and vision stand out as key drivers of a more trusted and resilient, globally connected pharmaceutical ecosystem. E