MoH and TGA signed an agreement to implement Regulatory Strengthening Program

MoH and TGA signed an agreement to implement Regulatory Strengthening Program

Photo Tatoli/Francisco Sony

DILI, 16 may 2023 (TATOLI)—The government’s Ministry of Health signed an agreement with Australia’s Therapeutic Goods Administration (TGA) to implement the Indo-Pacific Regulatory Strengthening Program (RSP) in Timor-Leste, to strengthen the capability of National Regulatory Authorities (NRAs) to increase the availability of safe and effective medicines and medical devices.

The agreement was signed today by the Minister of Health, Odete Maria Freitas Belo, and the Assistant Secretary International Regulatory Branch Medicines Regulation Division, Michael Wiseman at the Ministry of Health office, Caicoli, Dili.

Timor-Leste Minister of Health, Odete Maria Freitas Belo said, this agreement aims to strengthen the Ministry of Health National Regulatory Authority, working under the General Director of Service Delivery tutelage.

“In relation to the Partnership for a Healthy Region by 2023-2027 launched by the Government of Australia, the country needs to learn and ensure the capacity of the Ministry of Health to deeply analyze, and there will be a chance to adapt, adjust, harmonize and complement the existing document such as any legal document include rules and procedures related to the access to the high quality, safe and effective products for diagnosis, treatment, and prevention of infection disease threats in our country specifically and automatically for the benefit of the Pacific Region,”

Moving for quality, effective, and safe medicines, Belo said, it is important to ensure the accessibility and affordable of the product for diagnosis, treatment, and prevention:” In this scene, I’m trying to emphasize my / Ministry of Health Responsible for the area of medicines and medical devices to also take attention in working together with the relevant department (Hospitals, CHS and Post) to analyze the epidemiology information linked to the selection, specification, and quantification or let me say about issues of forecasting,”

Another crucial subject is the process of how to obtain (I mean the procurement issues) medical goods in small quantities for the 1.3 million population with different diseases such as for Communicable disease and Non Communicable diseases, vaccines, Family Planning Commodities, Nutrition items, and environment health items. 

She added that a Decree Low for the procumbent of Medicines and Medical Products, unfortunately, was revoked. 

“I assume that this partnership will bring all of us, in one context that the quality, safe and effective use of medicines is one circle that could not break. Please take a consideration that this country is completely dependent on the manufacturers outside the country, therefore there will be a long list of factors that can affect the access, affordability, quality, safe, and effectiveness of those medical products.,”

Michael Wiseman said that the Government of Australia provides support to Timor-Leste, to help build the capacity and capability of the Timor-Leste Nationalist Regulatory Medicine Authority to identify the quality of medicine.

“We would help with the system, with the process and help build with the capability of the people that are working there, to make sure that medicine that available in Timor-Leste are of high quality, safe and effective,” Wiseman told the media during the interview. 

According to Wiseman, this program is funded by Australia’s government through TGA to do the testing on behalf of the country in the Pacific, and Timor-Leste is one of those countries.

“So we have the opportunity to do tests in Timor, to make sure the medicine that supplies in Timor-Leste make a proper stand of its quality,”

He added the test is normally conducted five per year but in the event of being in serious problem with medicine, the country are able to request additional test again or possibly to do more test.

“So, therefore, People who have the responsibility to supply the medicine, hope that the medicine is of quality,”

Meanwhile, the presence of the TGA in Timor Leste during these 2 days, will be participated by the relevant staff in the Ministry of Health especially the National Directorate of Pharmacy, SAMES, INSPTL, and other relevant departments. 

Journalist: Camilo de Sousa

Editor: Nelia Borges


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