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The World Health Organization (WHO) plays a pivotal role in supporting countries in strengthening their regulatory systems, and promoting equitable access to quality, safe, efficacious, and affordable medical products and health products.  WHO consider the role of the Drug Regulatory Authority (DRA) in a country as an essential part of the health system that contributes to the health status of the community. Inefficient drug control systems will make access barriers to safe, qualified and efficacious medicines and vaccines.

 

Indonesia is one of the exporting country of vaccine in South East Asia region to the low income countries. Indonesia has produced 12 vaccines that have been exported to 130 countries. Since 1997, 12 vaccine products from Indonesia has gained WHO recognition of the WHO Pre-Qualification (PQ). With such confidence, only a few vaccine producers have the capacity to supply vaccines for the prevention of infectious diseases around the world to improve global health quality. Exports of vaccines are conducted through global health agencies such as the United Nations Children 's Fund (UNICEF), the Global Alliance of Vaccines and Immunization (GAVI) and the Pan American Health Organization (PAHO), thereby the global harmonization of the pharmaceutical industry in Indonesia will contribute to global access of qualified vaccine products from Indonesia. National Agency of Drug and Food Control (NADFC) ensures the quality, efficacy and safety of medicines, including vaccines in order to provide benefits in the framework of patient safety. NADFC control activity starts from the process of assessment of efficacy, safety and quality of the drugs, supervision of production process in accordance with Good Manufacturing Practice (GMP), supervision of distribution in accordance with Good Distribution Practice (GDP) including cold chain products, and also post market safety surveillance through pharmacovigilance activities.

 

On July 9 – 13 , 2018 WHO conducted National Regulatory Authorities (NRA) Benchmarking to see the regulatory system status in Indonesia especially for vaccine products. Through this NRA Benchmarking, it is expected to identify the strength and gaps for regulatory system for vaccines and also improvement activity that should be implement by NADFC. This NRA Benchmarking is a re-benchmarking after assessment conducted in 2012 where NADFC has fulfilled WHO indicators as regulatory authority for vaccines.

 

The NRA Benchmarking includes 9 regulatory functions i.e.:

1.       National Regulatory System (NRS)

2.       Registration and Marketing Authorization (MA)

3.       Vigilance (VL)

4.       Marketing Surveillance and Control (MSC)

5.       Licensing Premises (LIC)

6.       Regulatory Inspection (RI)

7.       Laboratory Access and Testing (LAT)

8.       Clinical Trial’s Oversigth (CTO)

9.       NRA Lot Release (LTR)

 

Post-market vaccine safety monitoring through pharmacovigilance activity is one of the functions carried by the Directorate of Safety, Quality, and Export Impor Control of Drugs, Narcotics, Psychotropic, Precursors and Addictive Substances, NADFC. WHO assess the vigilance function by using WHO Global Benchmarking Tools consists of 6 indicators. These indicators include the legislation underlying the implementation of pharmacovigilance, the position of pharmacovigilance functions in governance, human resources, operational standards of procedures, transparency and disclosure of information to the public, as well as monitoring and evaluation of key performance indicators related to pharmacovigilance activities.

 

Reporting of Adverse Drug Reactions (ADRs) and Adverse Event Following Immunization (AEFI) is an important aspect of post-marketing safety surveillance activities. NADFC as the National Center Pharmacovigilans in Indonesia is required to be able to encourage healthcare professional and pharmaceutical industry in reporting ADR and AEFI. Evaluation of aggregate data and trend analysis is expected to present ADR and AEFI profiles that describe post-marketing safety surveillance. Some of the work plans proposed by NADFC in order to improve the performance of Vigilance (VL) functions include the establishment of regional pharmacovigilance centers in Provincial Office of NADFC, training of Provincial Office of NADFC staff, healthcare professional and pharmaceutical industries as well as participation in various regional and international pharmacovigilance training.

 

In addition, the coordination between NADFC with The Expanded Programme on Immunization (EPI) and National Committee of AEFI also has important role in the implementation of pharmacovigilance activities for vaccines. WHO also conducted AEFI Site Visit to Kebon Jeruk Public Health Facility and Pasar Rebo Hospital to see the AEFI vigilance activities in health facilities.

 

WHO appreciates the performance of NADFC in implementing 9 regulatory functions as seen on the satisfactory result of the NRA benchmarking. With this result, NADFC confident to fulfill the function as the national regulatory authority to ensure the drug safety for patient safety. 

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