CROSS-STANDARD public interest · PPE / respirator (mask)
China-to-Pakistan PPE Respirator (FFP / KN95) Compliance Gap Matrix
AI-compiled from official public sources — cross-checked by multiple AI models, not human-verified. Informational only; see disclaimer. Public-interest, source-linked comparison of Chinese PPE respirator (KN95 / GB 2626) documentation against Pakistan market requirements under the Pakistan Standards and Quality Control Authority (PSQCA) Act 1996, the Conformity Assessment Scheme, Pakistan Standards (PS) adopting EN 149, the occupational health and safety / labour-law framework, in-country importer obligations, and the separate medical-mask pathway through the Drug Regulatory Authority of Pakistan (DRAP).
Dataset 2026-06-11
Last verified 2026-06-15
6 rows
GAP MATRIX
Compliance Gap Matrix
| Compliance item | Common China baseline | Pakistan (PSQCA) | Gap / action | Source + verification date |
|---|---|---|---|---|
| Conformity Assessment — PSQCA Mandatory Certification and Pakistan Standards (PS) | For industrial respiratory protection under GB 2626-2019 (KN95), China applies a compulsory certification (CCC) scheme administered by CNCA/SAMR and third-party certification bodies (e.g., China Quality Certification Centre, CQC), comprising type testing by a CNAS-accredited laboratory plus factory inspection. For medical-protective masks (GB 19083), NMPA registration as a Class II medical device is required. Neither the Chinese CCC scheme nor NMPA registration is automatically recognised by PSQCA. PSQCA conformity assessment must be obtained against the applicable Pakistan Standard, and because that standard adopts EN 149 (not the GB test method), Chinese GB 2626 test data does not directly map onto the Pakistani specification.GB 2626-2019 — Respiratory protective equipment — Non-powered air-purifying particle respirator (CCC mandatory certification under CNCA/SAMR) GB 19083-2010 — Technical requirements for medical protective mask (NMPA Class II medical device registration) |
The Pakistan Standards and Quality Control Authority (PSQCA), established under the PSQCA Act 1996, is the national standards body and the conformity assessment authority for Pakistan. PSQCA formulates and adopts Pakistan Standards (PS) and operates a Conformity Assessment Scheme (CAS) for products placed on its mandatory list. Where a respirator falls under PSQCA's mandatory items, conformity is demonstrated through PSQCA certification, which involves submission of test reports against the applicable Pakistan Standard, factory/quality assessment, and a licence to use the PS conformity mark. Pakistan's respirator standard adopts the EN 149 filtering-facepiece methodology rather than the Chinese GB test methodology. Because Pakistan does not operate an EU-style multi-module Notified Body system, conformity is handled administratively by PSQCA (or an accredited conformity assessment body) rather than by a privately appointed Notified Body. Imported goods additionally require an in-country importer of record for customs clearance and PSQCA registration. There is no separate EU-style horizontal PPE regulation in Pakistan; occupational use is governed by provincial labour / factories legislation (see the safety fragment).Pakistan Standards and Quality Control Authority Act, 1996 (PSQCA Act) — establishes PSQCA, Pakistan Standards (PS), and the Conformity Assessment Scheme PSQCA Conformity Assessment Scheme (CAS) — mandatory certification and PS conformity mark licensing for items on the mandatory list Pakistan Standard (PS) for filtering facepiece respirators adopting EN 149 — filtering half masks to protect against particles |
The conformity assessment must be re-run with PSQCA against the applicable Pakistan Standard. Specific gaps: (1) The applicable Pakistan Standard adopts EN 149 methodology, so GB 2626 (KN95) NaCl-only test data is not directly accepted — testing/evidence aligned to EN 149 is expected; (2) Chinese CCC certificates and NMPA registrations do not substitute for PSQCA certification; (3) A PSQCA licence to use the PS conformity mark must be obtained before the product is treated as compliant for the mandatory list; (4) An in-country importer of record (with a Pakistan business presence) is required for customs clearance and PSQCA registration — there is no exporter self-certification route; (5) Surgical/medical masks fall under DRAP, not PSQCA, so the correct authority must be identified first (see scope fragment); (6) Pakistan has no EU-style horizontal regimes (RoHS, battery regulation, outdoor-noise) applicable to this product, so no separate horizontal conformity is owed — but the PSQCA/PS route is mandatory where listed.[INFORMATIONAL] Filtering respirators on PSQCA's mandatory list require PSQCA conformity assessment against the applicable Pakistan Standard (which adopts EN 149) and a licence to use the PS conformity mark, plus an in-country importer of record. Chinese CCC and NMPA certifications are not automatically accepted, and GB 2626 (KN95) NaCl-only test data does not map directly to the EN 149-based PS specification. Surgical/medical masks follow the DRAP route instead. Pakistan does not impose EU-style horizontal regimes (RoHS, battery, outdoor-noise) on this product. | Pakistan Standards and Quality Control Authority (PSQCA)2026-06-15 · reference |
| Product Labelling and Marking Requirements — FFP Respirators (PS adopting EN 149) | GB 2626-2019 Clause 7 specifies Chinese marking requirements for non-powered air-purifying particle respirators. Required on the product: manufacturer name or trademark, product name, product model, standard number (GB 2626-2019), performance class (KN90 or KN95), 'NR' or 'R' designation. Required on the packaging: manufacturer name, address and contact, production date and shelf life (or expiry date), lot number, storage conditions, and instructions for use in Chinese. The CCC mark must appear on the product and packaging. Key differences from the Pakistani expectation: Chinese markings are in Chinese and cite GB 2626; Pakistan expects EN 149 marking (FFP class, NR/R, D suffix) with the PS conformity mark, the in-country importer's details, and English/Urdu instructions.GB 2626-2019 — Clause 7 (Marking and packaging requirements) China CCC (3C) mark — mandatory product certification mark on product and packaging |
Because Pakistan's filtering facepiece respirator standard adopts EN 149:2001+A1:2009, the device marking expected on the product and packaging follows EN 149 Clause 9: (1) the standard reference (EN 149:2001+A1:2009, as adopted by the Pakistan Standard); (2) manufacturer name or trademark; (3) type/model designation; (4) performance class (FFP1 / FFP2 / FFP3); (5) 'NR' (not re-usable) or 'R' (re-usable); (6) 'D' if the dolomite clogging test was passed. In place of the EU CE-plus-Notified-Body-number, the Pakistani product/packaging carries the PSQCA-licensed PS conformity mark (see marking fragment). Packaging must show manufacturer name and address, the in-country importer's name and address, storage conditions, lot/batch number and shelf life where applicable, and instructions for use. Pakistan is a multilingual market with English and Urdu as the principal languages of commerce and regulation; importers should provide instructions for use in English and, as a practical matter, Urdu, and the importer's details must appear on the retail labelling. Pakistan does not impose EU-style 24-language instruction requirements, and it imposes no horizontal RoHS/battery/outdoor-noise labelling on this product.Pakistan Standard (PS) adopting EN 149:2001+A1:2009 — Clause 9 (Marking requirements) PSQCA Act 1996 — PS conformity mark on product and packaging Pakistan import / consumer labelling practice — importer name and address on retail labelling; instructions for use in English (Urdu in practice) |
Typical labelling gaps for Chinese manufacturers exporting to Pakistan: (1) STANDARD CITATION: the product should reference EN 149:2001+A1:2009 (as adopted by the PS) and use FFP1/FFP2/FFP3 classing, not GB 2626 / KN95 classing — labelling 'KN95' on a product presented against the EN 149-based PS is potentially misleading because the test methods differ. (2) CONFORMITY MARK: the CCC mark does not apply; the PSQCA-licensed PS conformity mark is expected on product/packaging. (3) IMPORTER DETAILS: the in-country importer's name and address must appear on retail labelling — a destination-specific requirement absent from Chinese domestic labels. (4) LANGUAGE: Chinese-only instructions are insufficient; English instructions are expected and Urdu is advisable for retail and worker comprehension, but Pakistan does NOT require the EU's full multi-language (e.g., 24-language) set. (5) LOT/SHELF LIFE: lot number and shelf life should be clearly shown for traceability. (6) NO HORIZONTAL LABELS: unlike the EU, no RoHS/battery/outdoor-noise labelling is owed for this product, so exporters should not carry over those EU label elements.[INFORMATIONAL] FFP respirators for the Pakistani market should carry EN 149-based PS marking (FFP1/FFP2/FFP3, NR/R, D suffix, standard reference) and the PSQCA-licensed PS conformity mark, with the in-country importer's name and address on retail labelling and instructions for use in English (Urdu advisable). Chinese-only labelling, the CCC mark, and GB 2626 / 'KN95' references are not appropriate for the EN 149-based PS route. Pakistan does not require the EU's multi-language instruction set, and no horizontal RoHS/battery/outdoor-noise labelling applies to this product. | Pakistan Standards and Quality Control Authority (PSQCA)2026-06-15 · reference |
| PS Conformity Mark, PSQCA Licence, and In-Country Importer of Record | China does not require a PS mark. Domestic conformity is demonstrated via the CCC mark (mandatory for GB 2626 respirators) or NMPA registration (for GB 19083 / YY 0469 medical masks). The CCC mark is affixed after certification by a CNCA/SAMR-authorised body. China's domestic conformity pathway does not require a Pakistani in-country importer of record; that is an import-side obligation specific to the destination market. The Chinese CCC mark and NMPA registration documents are not accepted by Pakistani authorities as evidence of PSQCA conformity.China CCC (3C) certification — CNCA/SAMR mandatory certification system for GB 2626-2019 industrial respirators NMPA medical device registration — for GB 19083 / YY 0469 medical masks |
Before placing a filtering respirator on the Pakistani market where it falls under PSQCA's mandatory Conformity Assessment list, the responsible party must: (1) Obtain a PSQCA licence to use the PS conformity mark, granted after the product is shown to conform to the applicable Pakistan Standard (which adopts EN 149) and after the associated factory/quality assessment; (2) Apply the PS conformity mark to the product/packaging as authorised by the licence — this is the Pakistani equivalent of the EU CE marking step, but it is an administrative PSQCA licence rather than a manufacturer self-declaration plus Notified Body number; (3) Operate through an in-country importer of record — a Pakistan-established business that imports the goods, is responsible for customs clearance, PSQCA registration, and is the point of contact for the authorities. There is no EU-style Notified Body four-digit number system; instead PSQCA itself (or an accredited conformity assessment body) administers the licence. Pakistan does not require an EU-style 'Declaration of Conformity' template, but importers must retain certification and test evidence for inspection. Pakistan does not apply EU-style horizontal marking regimes (RoHS marking, battery-symbol marking, outdoor-noise dB marking) to this product.PSQCA Act 1996 — PS conformity mark licensing and the Conformity Assessment Scheme PSQCA marking/licensing rules — authorisation to apply the PS conformity mark to product and packaging Pakistan import framework (FBR / Ministry of Commerce import policy) — in-country importer of record obligations for customs clearance |
Gaps to close for the Pakistani market: (1) PS CONFORMITY MARK: the product/packaging must carry the PSQCA-licensed PS conformity mark, not the Chinese CCC mark; CCC alone is not accepted. (2) PSQCA LICENCE: a licence to use the mark must be obtained against the applicable EN 149-based PS, including the factory/quality assessment — Chinese CCC certificates and NMPA registrations do not substitute for it. (3) IMPORTER OF RECORD: a Pakistan-established importer must be appointed to handle customs clearance and PSQCA registration; an exporter cannot place the goods on the market without this local entity. (4) EVIDENCE RETENTION: certification and test evidence must be retained and produced on inspection (no EU-style DoC template is mandated, but documentary proof is). (5) NO HORIZONTAL MARKS: unlike the EU, no RoHS/battery/outdoor-noise marking is owed — exporters should not assume EU horizontal marking requirements transfer to Pakistan.[INFORMATIONAL] For listed filtering respirators, Pakistan requires a PSQCA licence to use the PS conformity mark (granted against the EN 149-based PS plus factory assessment), the PS mark on the product/packaging, and an in-country importer of record for customs clearance and PSQCA registration. Chinese CCC marks and NMPA registrations are not accepted as substitutes. Unlike the EU, there is no Notified Body number, no mandated DoC template, and no horizontal RoHS/battery/outdoor-noise marking for this product — but documentary certification/test evidence must be retained for inspection. | Pakistan Standards and Quality Control Authority (PSQCA)2026-06-15 · reference |
| Filtering Facepiece Respirator Safety — Pakistan Standard (PS) adopting EN 149 Performance Requirements | China's primary standard for non-powered air-purifying particle respirators is GB 2626-2019, with classes KN90 and KN95. It is a mandatory national standard (GB, not GB/T) enforced by SAMR; KN95 requires ≥95% filtration efficiency against NaCl particles at 85 L/min. Key differences from EN 149 (the method Pakistan's PS adopts): GB 2626 uses sodium chloride (NaCl) aerosol only (EN 149 uses both NaCl and paraffin oil), does not require the practical performance / simulated workplace test, and lacks the dolomite clogging resistance test. A Chinese CNAS-accredited GB 2626 test report therefore does not directly satisfy the EN 149-based Pakistan Standard.GB 2626-2019 — Respiratory protective equipment — Non-powered air-purifying particle respirator (mandatory national standard, SAMR) GB/T 32610-2016 — Technical specification of daily protective mask (voluntary, general public — not industrial PPE) |
Pakistan's filtering facepiece respirator standard is a Pakistan Standard (PS) that adopts the EN 149 filtering-half-mask performance benchmark. EN 149:2001+A1:2009 specifies three performance classes: FFP1 (≥80% filtration), FFP2 (≥94% filtration, ≤8% total inward leakage), and FFP3 (≥99% filtration, ≤2% total inward leakage), with requirements covering filtration efficiency against both solid (NaCl) and liquid (paraffin oil) aerosols, inhalation and exhalation breathing resistance, CO₂ content of inhaled air, practical performance (simulated workplace) testing, dolomite clogging resistance, and flammability. By adopting EN 149, Pakistan aligns its respirator performance benchmark with the European method rather than the Chinese GB 2626 method. Demonstrating conformity to the PS is part of the PSQCA conformity assessment for listed items; for occupational deployment, provincial factories/labour legislation imposes an additional employer duty to supply suitable, effective respiratory protection to workers exposed to dusts and airborne hazards.Pakistan Standard (PS) adopting EN 149:2001+A1:2009 — Respiratory protective devices — Filtering half masks to protect against particles — Requirements, testing, marking PSQCA Conformity Assessment Scheme — demonstration of conformity to the applicable PS Provincial Factories Act / occupational health and safety legislation — employer duty to provide suitable respiratory protective equipment |
Exporters must demonstrate conformity to the EN 149-based Pakistan Standard as part of PSQCA certification. GB 2626-2019 (KN95) test reports do not directly satisfy the PS because: (1) EN 149 requires paraffin oil aerosol testing in addition to NaCl; (2) EN 149 requires a simulated workplace performance test (total inward leakage on human subjects); (3) EN 149 requires the dolomite clogging test for valve masks; (4) numeric filtration thresholds differ (KN95 = 95% NaCl only; FFP2 = 94% both aerosols + total inward leakage limit). Because Pakistan's PS adopts EN 149, evidence aligned to EN 149 (ideally from an ILAC/PNAC-recognised laboratory) is expected; partial bridging from a GB 2626 report alone is unlikely to be accepted by PSQCA. Separately, employers in Pakistan must meet provincial factories-act respiratory-protection duties when deploying the product in workplaces — a programme-level obligation absent from a pure product-test comparison.[INFORMATIONAL] Pakistan's filtering facepiece respirator standard is a Pakistan Standard adopting EN 149, so conformity (NaCl + paraffin oil filtration, total inward leakage, breathing resistance, dolomite clogging, flammability, FFP1/FFP2/FFP3 classing) is assessed on the EN 149 method via PSQCA — not the GB 2626 method. Chinese GB 2626 (KN95) NaCl-only test data does not directly satisfy the PS; EN 149-aligned evidence is expected. Occupational deployment also carries an employer respiratory-protection duty under provincial factories/labour law. | Pakistan Standards and Quality Control Authority (PSQCA)2026-06-15 · reference |
| Medical / Surgical Mask Safety — DRAP Medical-Device Pathway (Not the PSQCA PPE Route) | China regulates medical-protective and surgical masks as medical devices under NMPA: GB 19083-2010 (medical protective mask, ≥95% filtration, bacterial filtration efficiency, surface moisture resistance, pressure differential) and YY 0469-2011 (medical surgical mask). Both are NMPA Class II medical devices, distinct from the industrial GB 2626 (KN95) PPE route under SAMR/CCC. This mirrors the Pakistani split: China's NMPA medical-device masks correspond to Pakistan's DRAP medical-device route, while China's GB 2626 industrial respirators correspond to Pakistan's PSQCA/PS (EN 149) route. A GB 19083 / YY 0469 NMPA registration is not recognised by DRAP — separate DRAP registration is required.GB 19083-2010 — Technical requirements for medical protective mask (NMPA Class II medical device) YY 0469-2011 — Medical surgical mask — Technical requirements (NMPA Class II medical device) |
This row addresses respirators/masks carrying a MEDICAL or SURGICAL claim, which in Pakistan are regulated by the Drug Regulatory Authority of Pakistan (DRAP) as medical devices under the DRAP Act 2012 and the Medical Devices Rules, NOT by PSQCA. DRAP operates a risk-based registration/enlistment system for medical devices, requiring an authorised local representative/importer, device dossier, and labelling/quality evidence. A medical-protective or surgical mask (e.g., one claiming bacterial filtration efficiency, fluid resistance, or surgical use) must be registered/enlisted with DRAP. The filtering-facepiece PPE route covered in the safety-001 row is the PSQCA/PS (EN 149) route — a product cannot use the PSQCA route to place a medically-claimed mask on the Pakistani market. See the scope fragment (ppepk-scope) for the boundary decision.DRAP Act 2012 — establishes the Drug Regulatory Authority of Pakistan and its mandate over medical devices Medical Devices Rules (Pakistan) — risk-based registration/enlistment of medical devices, including surgical/medical masks Pakistan Standard (PS) for filtering facepiece respirators (EN 149) — the PSQCA PPE route, applicable only when the product carries no medical/surgical claim |
A Chinese NMPA medical-device registration (GB 19083 or YY 0469) does not confer Pakistani market access — DRAP registration/enlistment is a separate process requiring an authorised local representative/importer, a device dossier, and labelling and quality evidence. Key gaps: (1) DRAP registration is mandatory for any mask carrying a medical/surgical claim; the PSQCA route cannot be used for such products; (2) an authorised local agent/importer of record is required by DRAP; (3) the device dossier must demonstrate the relevant performance (e.g., bacterial filtration efficiency, fluid resistance for surgical masks) and quality-system evidence; (4) Pakistan does not grant EU-style harmonised-standard presumption of conformity, so citing GB or international standards does not by itself satisfy DRAP. Choosing the wrong authority (PSQCA instead of DRAP for a medically-claimed mask) results in customs holds or recall.[INFORMATIONAL] Masks carrying a medical or surgical claim are regulated in Pakistan by DRAP as medical devices under the DRAP Act 2012, not by PSQCA. Chinese NMPA registrations (GB 19083 / YY 0469) are not recognised by DRAP — a separate DRAP registration/enlistment with an authorised local representative is required. Exporters must first decide PSQCA (PPE) vs DRAP (medical device) per the scope fragment; the wrong authority causes customs holds. Pakistan grants no harmonised-standard presumption of conformity. | Drug Regulatory Authority of Pakistan (DRAP)2026-06-15 · reference |
| CRITICAL BOUNDARY: PPE Respirator (PSQCA) vs. Medical / Surgical Mask (DRAP) — Which Authority Applies? | China uses a three-track classification system for respiratory masks: (1) INDUSTRIAL / NON-MEDICAL: GB 2626-2019 (KN90/KN95) — particle respirators for occupational use, mandatory CCC, administered by SAMR; (2) MEDICAL-PROTECTIVE: GB 19083-2010 (≥95% filtration, medical-grade) — for highly infectious environments, administered by NMPA as a Class II medical device; (3) SURGICAL MASK: YY 0469-2011 (Medical surgical mask) — for surgical use, NMPA Class II medical device. The Chinese three-track system maps approximately onto Pakistan's two-authority split: GB 2626 (industrial) corresponds to the PSQCA/PS (EN 149) route, while GB 19083 and YY 0469 (medical) correspond to the DRAP medical-device route. The mapping is not 1:1 because KN95 (GB 2626) and the EN 149 FFP classes that Pakistan's PS adopts use different test methods.GB 2626-2019 — Non-powered air-purifying particle respirator (KN90/KN95) — SAMR/CCC GB 19083-2010 — Technical requirements for medical protective mask — NMPA Class II YY 0469-2011 — Medical surgical mask — Technical requirements — NMPA Class II |
In Pakistan, the regulator depends on the INTENDED PURPOSE declared by the manufacturer/importer: (A) FILTERING RESPIRATORS / NON-MEDICAL PPE (PSQCA ROUTE): products intended to protect the WEARER against airborne particles, dusts, or aerosols (occupational, industrial use) fall under the Pakistan Standards and Quality Control Authority (PSQCA), against a Pakistan Standard (PS) that adopts EN 149. Occupational deployment in workplaces is further governed by provincial labour / factories legislation that obliges employers to provide suitable protective equipment. (B) MEDICAL / SURGICAL MASKS (DRAP ROUTE): products intended for medical use, infection control, or surgical use — protecting the patient/environment from the wearer or used in a healthcare setting — are regulated as medical devices by the Drug Regulatory Authority of Pakistan (DRAP) under the DRAP Act 2012 and the Medical Devices Rules. DRAP operates a risk-based medical device registration/enlistment system. (C) DUAL-CLAIM PRODUCTS: a respirator that also carries medical/surgical claims can attract BOTH the PSQCA/PS pathway and DRAP medical-device registration, which is significantly more burdensome. Unlike the EU, Pakistan does not consolidate these into two harmonised regulations with formal harmonised standards lists; the boundary is administrative (PSQCA standards body vs DRAP medical regulator). Pakistan does not operate EU-style horizontal regimes (RoHS, battery regulation, outdoor-noise) over this product.PSQCA Act 1996 — Pakistan Standards (PS) and Conformity Assessment Scheme (filtering respirators protecting the wearer: PS adopting EN 149) DRAP Act 2012 and Medical Devices Rules — Drug Regulatory Authority of Pakistan (surgical/medical masks regulated as medical devices) Pakistan Standard (PS) adopting EN 149 — Filtering half masks to protect against particles Provincial Factories Act / occupational health and safety legislation — employer duty to provide suitable respiratory protection |
The single most important classification decision is: what does the product label and intended-use statement claim? (1) If the product claims WEARER PROTECTION against particles/dust (worker safety, industrial): the PSQCA/PS (EN 149) route applies, plus the employer-side occupational duty under provincial factories law. (2) If the product claims MEDICAL / SURGICAL use or infection control: DRAP medical-device registration applies. (3) If the product claims BOTH: both PSQCA and DRAP pathways can apply. COMMON EXPORT MISTAKE: Chinese manufacturers labelling KN95 (GB 2626) masks with 'surgical' or 'medical' wording to target multiple buyers risks pulling the product into the DRAP medical-device regime (registration, importer obligations) in addition to PSQCA. Identifying the correct authority BEFORE shipment avoids customs holds and re-labelling. Note that Pakistan does NOT provide EU-style harmonised-standard presumption of conformity, so referencing a standard does not by itself confer market access — PSQCA certification (or DRAP registration) is the operative step.[INFORMATIONAL — CRITICAL BOUNDARY] In Pakistan, filtering respirators protecting the wearer go through PSQCA against a Pakistan Standard adopting EN 149, while surgical/medical masks are regulated by DRAP as medical devices under the DRAP Act 2012. The two routes must not be mixed. Products carrying both worker-protection and medical/surgical claims can attract both PSQCA and DRAP requirements. Exporters must fix the intended-use statement before shipment; unlike the EU, simply citing a standard does not grant market access — PSQCA certification or DRAP registration is the operative requirement, and Pakistan applies no EU-style horizontal regimes (RoHS, battery, outdoor-noise) here. | Drug Regulatory Authority of Pakistan (DRAP)2026-06-15 · reference |
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SOURCES
Official-source register.
- Pakistan Standards and Quality Control Authority (PSQCA) · accessed 2026-06-15 · reference · used in 2 rows
- Pakistan Standards and Quality Control Authority (PSQCA) · accessed 2026-06-15 · reference · used in 1 rows
- Pakistan Standards and Quality Control Authority (PSQCA) · accessed 2026-06-15 · reference · used in 1 rows
- Drug Regulatory Authority of Pakistan (DRAP) · accessed 2026-06-15 · reference · used in 1 rows
- Drug Regulatory Authority of Pakistan (DRAP) · accessed 2026-06-15 · reference · used in 1 rows