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January 2021

VigiCarib’s Online Reporting Form for Adverse Events Following Immunization, and Reports about Falsified or Unregistered Vaccines in CARICOM

  • The CRS has launched an online reporting form for adverse events following immunization (AEFIs) to assist with vaccine safety monitoring among CARPHA Member States. Case reports about local events received by health professionals and market authorization holders may be entered into the form, and the CRS will direct the report to the respective ministry of health personnel for local follow up. This will assist Member States that are developing reporting forms and processes to receive and investigate reports from the field electronically. You can access the new form here.

December 2020

Products Recommended to CARICOM in 2020

  • The CRS continued to review medical products throughout the year, despite the decrease in the number of applications when countries locked down with the discovery of the novel coronavirus. Between January and December 2020, the CRS issued 71 product recommendations to Member States, inclusive of an orphan drug for a rare disease (satralizumab injection for neuromyelitis optica spectrum disorders), and two diagnostic test kits for COVID-19. Twenty-one product dossiers were still in queue at the end of the year, of which 15 are pending additional information from applicants. The average time for the CRS’ verification review for 2020 was 58 calendar days, inclusive of time spent waiting for responses from applicants. Despite these delays, the CRS’ turnaround time remains below the target maximum of 60 days. More product recommendations were made by the CRS in 2020 than in previous years: 2017 – 16 products, 2018 – 11 products, 2019 – 44 products.

November 5th, 2020

CARPHA’s Caribbean Regulatory System (CRS) and the Medicines Quality Control and Surveillance Department (MQCSD), in collaboration with the Pan American Health Organization (PAHO), hosted the CARPHA COVID-19 Health Rounds ‘Preparing for COVID-19 Vaccine Safety Surveillance in the Caribbean’.

  • The topics presented included: Covid-19 vaccine landscape and the need for vaccine safety surveillance (Dr Desiree Pastor, PAHO Advisor), System requirements for effective vaccine safety surveillance and the need for collaboration (Dr Jose Luis Castro, PAHO Advisor), and Role of CARPHA VigiCarib network in COVID-19 Vaccine Safety Surveillance (Dr Rian Marie Extavour, CARPHA-CRS). In all, 180 persons joined the webinar from Member States, Europe and the United States of America. Attendees included physicians, pharmacists, regulators, immunization officers, public health nurses and CARPHA staff.

May 2020

The CRS has implemented a verification review procedure to identify and recommend suitable medicines, vaccines and test kits granted emergency use authorization for COVID-19

  • This procedure enables Member States to identify medical products that have been assessed for quality, safety and efficacy for the diagnosis, prevention or treatment of COVID-19. To date, two test kits have been recommended to CARPHA Member States. This is likely due to only 3 applications submitted to date, the pending assessments of proven vaccines by trusted regulatory authorities, and the limited evidence for proven medicines to treat COVID-19.

October 2nd, 2019

CARPHA/CRS Successes in Guyana Highlighted at WHO Conference

Caribbean Regulatory Body to Implement Fee for Service

  • The CARPHA Caribbean Regulatory System (CRS) has announced that it will begin charging modest user fees to the companies that apply for medicines recommendation through the CRS, starting November 15, 2019.  The CRS became operational in early 2017 and has performed these duties free of charge for over two years. Companies have increasingly used the system and to date have submitted over 100 medicines applications, with the CRS recommending roughly 55 of these for accelerated registration in CARICOM Member States.  All are verified to be the identical medicines approved in a reference agency like the US Food and Drug Administration.   This ensures the availability of the same medicines as found in highly regulated markets in CARICOM.

User fees are an important part of a regulator’s budget because they pay for the services which ensure that operations are efficient and accountable, that decisions on whether or not to approve medicines occur on reasonable timeframes.  Most pharmaceutical companies welcome user fees because, it usually improves the performance of the regulator. This is especially important in the small states of CARICOM, which struggle to process the medicines applications they receive due to lack of human resources and adequate financing. Ultimately these efforts are to reduce harm and improve patient access to quality medicines.

“Today is an important milestone in the history of our cooperative efforts. Charging user fees to the industry that uses the CRS is a down payment on its sustainability and will ensure that we have an efficient and effective mechanism for regional regulation in the future. It is another step towards the fulfillment of a Caribbean Single Market Economy”, said Dr. Joy St. John, CARHA’s Executive Director.

 

CARPHA/CRS Successes in Guyana Highlighted at WHO Conference

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."

 
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