Snapshot

The Verification Review for Biotherapeutic Product Applications pathway has been developed by the Caribbean Public Health Agency (CARPHA) of CARPHA-CRS.

This pathway can be used where This FRP can be used for originator biotherapeutic products and their biosimilars. To be eligible for verification review, each product submitted to the CRS for verification should meet the following criteria: 1. Essential Medicine: The product is an essential medicine, as per the most recent Model List of Essential Medicines by the World Health Organization (WHO EML). 1.1 The active pharmaceutical ingredient and the dosage form must be the same as the listed medicine. Note: the dose strength may differ from the listed strengths (e.g. 250mg vs 100mg). 1.2 Products that are not listed on the WHO EML may be considered for CRS verification based on the public health need. In these instances, the CRS will consult with CARICOM’s Expanded Committee for Pharmaceutical Policy (TECHPHARM), comprised of Member State representatives for approval. 2. Market Authorization by a National Regulatory Authority of Reference a. The product has valid market authorization from one of the national regulatory authorities (RA) of reference recognized by the CRS for insulins or for originator and similar biotherapeutic products, and is on the market of the respective country; or b. The product has been favorably assessed by WHO and is included in the WHO list of prequalified medicines (WHOPQ)..

It is a verification review (a recognition pathway).

Regional regulatory initiatives can help optimize the efficient use of an agency’s resources. The following countries participate in this initiative/pathway: Belize Guyana Haiti Jamaica Suriname Trinidad and Tobago

When relevant, the agency relies on prior decisions from Argentina Australia Brazil Canada Cuba EU-EMA Iceland Japan Liechtenstein Mexico Norway South Korea Switzerland United Kingdom United States

Verification review takes approximately 4-8 weeks once the dossier satisfies the eligibility criteria. The review time may be reduced if new applicants hold in-person, telephone, or on-line meetings with the Caribbean Regulatory System (CRS) staff to familiarize themselves with requirements before making a dossier submission. Once the CRS verifies a product application favorably, a recommendation certificate and an assessment report are issued to the applicant. These are also shared with all CARICOM governments via official CRS focal points. In addition, the recommended product is published in the list of CRS recommended products on the CRS’ webpage http://carpha.org/What-We-Do/Programmes-and-Projects/CRS/Caribbean-Regulatory-System. The decision for market authorization or registration remains with the national regulatory authorities (NRAs) of CARICOM, where this process is applied (Belize, Haiti, Guyana, Jamaica, Suriname, Trinidad and Tobago). National regulatory authorities of CARICOM that conduct market authorization are asked to make a decision on whether to grant market authorization of CRS recommended products within 60 calendar days following the recommendation. However, the subsequent market authorization or import permit granted by Member States is primarily controlled by the individual states. At this stage, the applicant will need to complete any relevant local administrative forms, pay the nominal local user fee, and identify a local importer to distribute the product. The CRS may assist with this phase by communicating with the local NRA.