Each timeline below is the target stated by the regulator at the linked official source, not a guarantee of elapsed time. Clock stops, dossier preparation and inspections are not included unless the source says so.
Explore the HERMS approach and our solutions portfolio.
See also timelines for SFDA, MOHAP, EDE, EDA, EMA and FDA and the GCC central registration guide.
Australia (TGA)
- Standard registration: legislated 255 working days from acceptance for evaluation to the delegate decision. Official source
- Priority review: target timeframe of 150 working days. Official source
- Provisional registration: target timeframe of 220 working days from acceptance for evaluation. Official source
- COR-A reliance route: 120 working days, and COR-B: 175 working days, evaluation and decision timeframes. Official source
Bahrain (NHRA)
- Normal registration pathway: 35 working days. Official source
- Fast track registration pathway: 3 working days. Official source
Denmark (Danish Medicines Agency)
- New national applications 2026: performance requirement of a maximum of 240 days, excluding clock-stop. Official source
Ghana (FDA Ghana)
- High and low risk applications: 6 months (180 days). Official source
- Fast track applications: 3 months (90 days). Official source
Indonesia (BPOM)
- Drug registration evaluation: 120 working days. Official source
- Reliance mechanism: 90 working days. Official source
Malaysia (NPRA)
- Full evaluation of new drugs and biologicals: 245 working days. Official source
Netherlands (CBG-MEB)
- National procedure: up to 210 days to reach a final decision. Official source
Norway (Norwegian Medical Products Agency)
- National procedure: within 210 calendar days after submission of a valid application. Official source
Oman (Ministry of Health Oman)
- Register a pharmaceutical product: service completion period of 360 working days. Official source
Philippines (FDA Philippines)
- Abridged review: not more than 45 working days. Official source
- Verification review: not more than 30 working days. Official source
Spain (AEMPS)
- National procedure: maximum of 210 calendar days from validation of the application. Official source
United Kingdom (MHRA)
- Innovative medicines: positive decision within 150 clock-on days if all issues are resolved after one round of questions. Official source
- Established medicines applications: final decision within 210 days. Official source
Canada (Health Canada)
- Standard new drug submission: review target of 300 calendar days; priority review: 180 calendar days; Notice of Compliance with conditions pathway: 200 calendar days. Official source
Finland (Fimea)
- National procedure: processing time of 210 days, not including the time the applicant spends answering requests for clarification. Official source
South Korea (MFDS)
- GIFT fast-track products: assessment timeline shortened to up to 75% of the usual review time, from 120 to 90 working days. Official source
Sri Lanka (NMRA)
- Decision on the application within a timeline of 90 days, subject to stop-clocks, under the procedure described on the NMRA page. Official source
Sweden (Swedish Medical Products Agency)
- National procedure: three rounds with a total processing time of 210 calendar days. Official source
Nigeria (NAFDAC)
- Drug registration: completed within 240 working days from acceptance of the application. Official source
How HERMS supports
HERMS Consultancy DMCC, Dubai, supports healthcare and life sciences organisations across the product lifecycle, from regulatory and market access to marketing, supply, pharmacovigilance, compliance and quality.