Bio Farma : Sharing experience in acquiring WHO Pre-qualification to OIC Member Countries
M. Rahman Roestan, President Director of Bio Farma, has been invited to speak on Bio Farma’s experience in acquiring WHO pre-qualification for Vaccines, at The First Meeting of Heads of National Medicines Regulatory Authorities (NMRAs) held by National Agency of Drug and Food Monitoring (BPOM) of Indonesia.
Rahman said,“currently Bio Farma has more than 12 vaccine products WHO pre-qualified. In order for a vaccine manufacturer to have its vaccines WHO pre-qualified, it is mandatory for the National Regulatory Agency (NRA) of the country to be accredited by WHO. This verifies that the NRA is functional, meeting all the indicators outlined by WHO. I take pride that our National Agency for Drug and Food Monitoring (BPOM) is WHO accredited”.
Penny Lukito, Head of BPOM added, "There are only seven OIC members states having the ability to manufacture vaccine". Penny stated that Indonesia is very fortunate to have Bio Farma a state-owned enterprise and the sole vaccine and antisera manufacturer for human use. The company has not only supported the National Immunization Program through the supply of vaccines, but exported its products to more than 140 countries as well, of which 49 are OIC member countries.
Rahman added, “Numerous OIC member countries such as Morocco, Tunisia, Turkey have procured vaccines from Bio Farma, including Saudi Arabia. Apart from exporting our vaccines, we are also open to discuss technology transfer for down stream production of vaccines to support OIC member countries in attaining self-reliance on vaccines. Joint research could another option for collaboration”.
The meeting will be held in response to the strong urge among OIC Countries to be self-sufficient and ultimately self-reliant in drugs including vaccines, through, among others, strengthening of the countries’ National Regulatory Authorities.
Bio Farma is a state-owned producer of Vaccines and Antisera, currently developing into a Lifescience company. More than 140 countries have used Bio Farma Vaccine products, especially developing countries, and 49 of them are countries that are members of the Organization of Islamic Cooperation. Bio Farma is the largest vaccine manufacturer in South East Asia.
For further information refer to website www.biofarma.co.id
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