Tuesday, July 23, 2019

Drug bill to help speed up registration of new medicines

Nov 13. 2018
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THE NEW drug bill will allow specialists and their organisations, foreign or Thai, to review drug registration applications.

“This aims at speeding up the registration process so people can have quicker access to useful medicines,” Government Spokesman Puttipong Punnakanta said yesterday. He was speaking after the Cabinet approved the new drug bill, which was drafted to replace the current Drug Act. 

“The current drug law was put in effect in 1967, and many parts of it are no longer relevant in today’s context,” he explained. 

Under the Act, the Food and Drug Administration (FDA) is the only agency that can review applications and approve medicines. Sometimes, work hits a bottleneck, and registration gets delayed. 

“But the new bill will allow the FDA to appoint specialists to screen applications for its final review,” Puttipong said, adding that the FDA will not be required to submit a list of specialists to any authority. 

However, the FDA will be required to give the application fees to the Finance Ministry. 

Puttipong said the bill will also raise the ceiling for application fees from Bt10,000 to Bt50,000. Also, once the new bill becomes law, drug licences in Thailand will for the first time have expiry dates. 

“The licence will have to be renewed every five years,” he said. 

Over the past few months, this bill has faced opposition from pharmacists, who feel some clauses threaten their occupation prospects and fail to adequately protect consumers. These are clauses on governing pharmacies and persons authorised to dispense drugs. 

The Public Health Ministry, however, has decided to push the bill forward. 


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