Caribbean Regulatory System recommends first generic drugs for sale in the region

Four essential generic medicines for HIV treatment were assessed and recommended for sale in May by the Caribbean Regulatory System (CRS) in one of its first actions advising government on medicines regulation in Caricom.

According to a media release from Pan American Health Organisation/World Health Organisation (PAHO/WHO), the Caribbean Public health Agency (Carpha)/ CRS recommended manufacturer’s versions of four products, including Emtricitibine/Tenofovir and Tenofovir tablets, used in treatment of HIV. The regional initiative to help Caribbean states perform key regulatory functions is a collaboration between Caricom and Carpha, with the support of PAHO/WHO.

The PAHO/WHO release said that the states of Caricom can be individually limited in their capacities to assess medicines for safety, quality and efficacy. It further noted that the states can struggle sometimes with having the resources to conduct assessments, including for quality, and in a timely fashion.

According to the press bulletin, the Carpha/CRS requires that the medicines it examines have already gone through rigorous regulatory scrutiny, and are approved by a trusted regulatory entity, such as the US Food and Drug Administration, or the Brazilian Authority, ANVISA. The four recommended HIV products are approved by the WHO Prequalification of Medicines Programme. The Carpha/CRS also requires that the medicines it assesses are listed on the WHO Essential Medicines List, most of which are generic.

After recommendation, the process then continues at the state level, according to the PAHO/WHO release, where the Carpha/CRS assessment helps governments make a decision on authorization within an accelerated timeline, thus speeding access for patients. As more pharmaceutical companies use Carpha/CRS, a list of favourably evaluated products will be created, which governments can use in authorization and procurement decisions.

According to the media statement, the Carpha/CRS creates a single portal of entry to the different Caricom markets which comprises 17 million people, with one set of requirements, facilitating economies of scale. Since the system focuses on assessing generic medicines, this increases competition and lowers prices for patients and governments, and also ensures the quality of medicines to prevent substandard and falsified drugs from proliferating on the market.