REPUBLIKA.CO.ID, JAKARTA -- President Director of Bio Farma M Rahman Roestan will be 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 Control (NADFC) of Indonesia (Jakarta, 20th-22nd of November 2018).
“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 Control (NADFC) is WHO accredited,” Rahman said.
"There are only seven OIC members states having the ability to manufacture vaccines," Head of the Indonesia NADFC Penny Lukito added.
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. 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,” Rahman added.
Penny stated that currently there is no special forum for Drug Regulatory Authorities of OIC countries. She stressed the strategic role of such a forum in strengthening regulatory oversight ensuring that drugs, including vaccines, meet the requirements of efficacy, safety, and quality.
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.
Prior to the NMRAs Meeting which will be held on 21st-22nd November, a business forum will be organized on 20th November convening pharmaceutical industries from OIC Member Countries, along with government representatives. There will also be a pharmaceutical exhibition showcasing medicinal products from various OIC Member Countries on 20th-22nd November 2018 and factory visit to Bio Farma located in Bandung, West Java province.
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