WHO Maturity Level 3: why DRAP’s next step could open 100 new export markets
Pakistan is at WHO Maturity Level 2 and exports medicines to 52 countries. The health minister expects Level 3 by April 2027.
In this article
For a medicine exporter, the strength of the home regulator is part of the product. That is why WHO’s rating of the Drug Regulatory Authority of Pakistan (DRAP) has become an industry priority.
Where Pakistan stands
- Pakistan is currently at WHO Maturity Level 2 and exports pharmaceutical products to 52 countries, Health Minister Syed Mustafa Kamal told the Senate in August 2026.
- He said Level 3 accreditation would move Pakistan towards opening more than 100 additional markets.
- In July 2026, he said he expected Level 3 by April 2027, and that 80% of DRAP’s services were now online.
What is being done
The minister has directed DRAP to speed up the reforms and prepare a roadmap with timelines, Profit reported. Upgrades to the Central Drugs Laboratory, the country’s main medicine testing facility, are part of the plan, with international accreditation intended to align testing with global practice. In June 2026, DRAP was also designated an Observer of the International Council for Harmonisation (ICH).
Why it matters
| Benefit cited by the government |
|---|
| Greater credibility of Pakistani medicines abroad |
| Access to international markets and investor confidence |
| Joint ventures with global firms |
| Higher exports of locally made medicines |
What the maturity levels mean
WHO assesses national medicine regulators with its Global Benchmarking Tool. The tool looks at the whole regulatory system and at each of its main functions: registration and marketing authorisation, vigilance (monitoring side effects), market surveillance and control, licensing of manufacturing sites and distributors, inspections, laboratory testing, oversight of clinical trials and, for vaccines, lot release.
The results are expressed as four maturity levels:
- Level 1 — some elements of regulation exist.
- Level 2 — an evolving national system that partially performs the essential functions.
- Level 3 — a stable, well-functioning and integrated regulatory system.
- Level 4 — a system operating at an advanced level of performance with continuous improvement.
Level 3 is the threshold that matters internationally. It signals to other regulators, international buyers and procurement agencies that a country’s medicines are authorised, inspected and monitored by a regulator that works reliably.
Why buyers care
When a foreign regulator or a large buyer considers a Pakistani product, it is also assessing the system behind it: who inspected the factory, how the product was approved and how problems would be detected. A higher WHO rating makes that assessment quicker and more favourable. It can shorten registration in new markets, support reliance arrangements in which one regulator draws on another’s work, and strengthen the case for international procurement and partnerships.
What has to change
Reaching Level 3 is less about one big reform than about many functions working consistently: documented procedures, trained inspectors, timely decisions, an accredited testing laboratory and transparent information. The government’s stated plan — a roadmap with timelines, the Central Drugs Laboratory upgrade and more services online — targets exactly those areas. DRAP’s observer status at the International Council for Harmonisation adds a second track: closer alignment with the technical guidelines that regulators in major markets use.
A step-by-step process
A WHO benchmarking is not a single exam. The regulator first assesses itself against the tool’s indicators, then WHO experts review the evidence and visit, and agree an improvement plan with the authority. Once the gaps are closed, a formal assessment confirms the new level. Progress is therefore visible along the way — in published procedures, faster decisions and more transparent information — well before the final rating is announced.
What it means for manufacturers
A stronger regulator raises the bar at home as well as opening doors abroad. Plants that expect to export will need GMP systems that stand up to closer scrutiny — see DRAP’s PIC/S plan — and the laboratories, documentation and equipment to match.
Regulatory readiness is a recurring theme of the International Pharma Convention at Pharma Asia.
Sources
- The Express Tribune, “Pakistan eyes 100 new pharma export markets”, 26 August 2026
- Digital Pakistan, “Pakistan-China pharma summit seals $850m in investment pacts”, 20 July 2026
- Profit by Pakistan Today, “Pakistan accelerates drive for WHO maturity level 3 in drug regulation”
- APP, “Pakistan becomes ICH Observer, marking another international regulatory milestone for DRAP”, 5 June 2026
