NPRA yet to receive COVID-19 vaccine evaluation registration document from Pfizer

NPRA yet to receive COVID-19 vaccine evaluation registration document from Pfizer

The Health Ministry’s National Pharmaceutical Regulatory Agency (NPRA) has so far not received any documents from Pfizer for evaluation registration and testing of the COVID-19 vaccine, said Health director-general Tan Sri Dr Noor Hisham Abdullah.

He said the ministry has no direct information on whether there have been some problems in the supply of the vaccine as reported by a foreign media agency.

“The Health Ministry, however, will monitor developments on the Pfizer’s COVID-19 vaccine and obtain more information on the matter.

“The ministry will notify the public on developments from time to time,” he said in a statement today.

Dr Noor Hisham was commenting on a Reuters report on Dec 4 which, among others, said that the pharmaceutical company may not be able to meet its production target for the vaccine for 2020 due to a lack of raw materials.

He said it was the NPRA’s responsibility to ensure all products go through the evaluation and testing process based on the principles of quality, safety and effectiveness before being registered for the Malaysian market.

Apart from that, he said NPRA also ensures that the quality, safety and effectiveness of vaccines and registered medicines are always guaranteed through the quality product monitoring program and pharmacovigilance. - Bernama



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