Guyana’s successes related to regulatory strengthening was recently highlighted by the Director of the Guyana National Regulatory Authority, Marlan Cole, at the biannual WHO International Conference of Drug Regulatory Authorities (ICDRA) in Dublin, Ireland.
Director Cole indicated that a key to Guyana’s strategy has been to rely on the Caribbean Public Health Agency's Caribbean Regulatory System's (CARPHA/CRS) recommendations for market authorization of imported medicines, seeking approval in Guyana. This has decreased the workload on the national regulatory staff and permitted faster market entry of quality products.
In addition, the CRS has not issued recommendations for unqualified products, effectively filtering lower quality medicines from entering the Guyana market. Director Cole stated the CRS has been valuable in helping to improve market surveillance.
A recent workshop for CARICOM States on use of the WHO Global Surveillance and Monitoring Systems for Substandard and Falsified products, revealed an unregistered and falsified biosimilar on the Guyana market. The implicated company is now facing enforcement action. Director Cole said that part of the country’s success in implementing the CRS was educating the local industry and maintaining a public health position in the face of a court challenge by one company.
According to CARPHA’s Director, Dr James Hospedales, "The CRS is a great example of how CARPHA is delivering needed public health services to CARICOM member states, and the collaboration with Guyana is a model for others.” He also said that "The mechanism will only gather strength over time, as awareness and uptake builds."