Department of Health reviews pharmaceutical drug registration process – Jamaica Information Service

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Highlights of history

  • The Ministry of Health is undertaking a review of the registration process for pharmaceutical drugs, in an effort to achieve a more modernized system.
  • Minister of Health, Dr the Hon. Christopher Tufton says the modernization process will include digitizing records to reduce the average time it takes to register a drug.
  • The Minister was addressing the opening of a two-day meeting on postmarketing surveillance and drug policy in the Caribbean, at the Department of Drug Quality Control and Surveillance of the Caribbean Public Health Agency (CARPHA), at Hope Gardens in St. Andrew on March 12. .

The Ministry of Health is undertaking a review of the registration process for pharmaceutical drugs, in an effort to achieve a more modernized system.

Minister of Health, Dr the Hon. Christopher Tufton says the modernization process will include digitizing records to reduce the average time it takes to register a drug.

The Minister was addressing the opening of a two-day meeting on postmarketing surveillance and drug policy in the Caribbean, at the Department of Drug Quality Control and Surveillance of the Caribbean Public Health Agency (CARPHA), at Hope Gardens in St. Andrew on March 12. .

Dr Tufton said vigilance is required for drug companies wanting to have a foothold in Jamaica, and believes there should be standardization in drug registration for these companies.

“They need to be known, monitored and registered, so that they can enjoy maintaining established standards,” he said.

Dr Tufton argued that post-market surveillance of pharmaceuticals is essential to guard against the possibility of misuse, for the benefit of people across the Caribbean.

The Minister stressed that a collaborative effort is needed on the part of the Caribbean region in this regard.

“We have a duty to protect our people. The way the drug market is configured between original (drug) and generics, which follow over time … you really have to sift through what is what and who is in the best interests of those we let’s serve, ”he said.

Dr Tufton said that according to data, over the past six months, on a monthly basis, more than 200 adverse drug reaction reports have been submitted locally to the Department’s Pharmacovigilance Unit.

Meanwhile, Dr Virginia Asin-Oostburg, director of the Surveillance, Disease Prevention and Control Division at CARPHA, said post-market surveillance is a new agenda and will be further shaped through close collaboration with Member States and other agencies.

For her part, the subregional program coordinator for the Caribbean at the Pan American Health Organization / World Health Organization, Jessie Schutt-Aine, said that a strong regulatory system is the basis of a strong regulatory system. of solid health, necessary for universal health.

Minister of Health, Dr the Hon. Christopher Tufton (left), greets the Caribbean Subregional Program Coordinator at the Pan American Health Organization / World Health Organization, Jessie Schutt-Aine (second from right), at the opening of ” a two-day meeting on Post-Market Surveillance and the Caribbean Drug Policy, at the Department of Drug Quality Control and Surveillance, Caribbean Public Health Agency (CARPHA), at Hope Gardens in St. Andrew, March 12. Dr Rudolph Cummings, and Acting Chief / Senior Chemist at CARPHA, Sonia Thomas-Gordon.

“PAHO has been working on these issues for many years, supporting the development of the Caribbean drug policy as well as the roadmap for the regional regulatory platform. More recently, PAHO has worked closely with CARICOM, CARPHA and Member States to advance the implementation of the Caribbean regulatory system, ”she said.

The registration of drugs and other items or products is the main regulatory function performed by the Department of Pharmaceutical and Regulatory Affairs of the Ministry of Health.

The process involves a thorough scientific evaluation of the technical documentation submitted in support of registration, resulting in the approval of a drug or other related products.

It is one of the main mechanisms by which the quality, safety and efficacy of drugs and other products referred to in the Food and Drugs Act and Regulations are ensured.


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