News
Cancer drug without registration: NMRA claims correct procedure followed
View(s):The National Medicines Regulatory Authority Chairman, Dr Rasitha Wijewantha, has drawn our attention to last week’s news item headlined “Cancer drug to be imported without registration.”
The NMRA Chairman said: “Trastuzumab Powder for injection, Brand Name Herzuma, manufactured by Celltrion INC Republic of South Korea, and Marketed by George Steuart’s Health (Pvt) Ltd was given registration/marketing authorization by the NMRA on the 10th of November 2021, following the correct procedure after a careful evaluation and approval of the medicines evaluation committee and price negotiation.
“Hence the news item, which stated that the medicine was given a waiver of registration to import the product is totally incorrect and misleading. Also there is no requirement of waiver for importing registered medicines.”
Reporter’s /News Editor’s note: The confirmation that the above drug had been provided a waiver of registration was given by the NMRA Chairman himself and was quoted accordingly in the news item published.
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