Agence sénégalaise de Réglementation pharmaceutique (ARP) ECOWASECOWAS Joint Assessment Procedure (ECOWAS JAP)
ECOWAS Joint Assessment Procedure (ECOWAS JAP) is the official ARP identifier for “ECOWAS Joint Assessment Procedure (ECOWAS JAP) for medicine registration and marketing authorization of medicinal products”. ECOWAS Joint Assessment Procedure (ECOWAS JAP) is the official identifier ARP uses for this instrument.
- Instrument
- ECOWAS
- Full name
- ECOWAS Joint Assessment Procedure (ECOWAS JAP)
- Category
- General
- Authority source
- English
- Readable HTML
- 23 articles · 1 language version
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ECOWAS Joint Assessment Procedure (ECOWAS JAP) for medicine registration and marketing authorization of medicinal products
A REGIONAL INSTRUMENT, and a MEDICINES one: the ECOWAS Joint Assessment Procedure run by the West African Health Organisation (WAHO/OOAS) under West Africa Medicines Regulatory Harmonization, in which a medicine dossier is assessed once by a coordinating national regulator and an expert working group and the outcome is then acted on nationally. It sets out the scope of products, the joint assessment pathway step by step (expressions of interest, the pre-submission meeting, dossier submission and screening, the evaluation phases, the joint GMP inspection and quality-control testing, the steering-committee validation), the reporting of results, the outcome, maintenance of registration status, national authorisations and the WHO collaborative assessment pathway alongside it. It is filed under ONE market — Senegal, this batch's market — under the round's rule for instruments that apply across several countries. It is NOT a medical device instrument and this row does not claim it is: the batch triage note carried the lead inside a device workstream, and the correction is that the procedure is for medicinal products, so it is recorded here as the regional medicines procedure a Senegalese device applicant reads only for the shape of joint assessment, with no device obligation arising from it. The copy is dated September 2022 on its cover.
ECOWAS Joint Assessment Procedure (ECOWAS JAP) is the official identifier ARP uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.