Applications for the registration of more than 35 new medicines, following the fulfillment of all the conditions and procedures, have been approved the Ministry of Health, (MoH) said on Thursday.
The Committee for the Registration and Pricing of Pharmaceutical Manufactures and Products, chaired by Dr. Mohammed Hamdan Al-Rubaie, Director General of Pharmaceutical Affairs and Drug Control, held its third meeting in 2021 to discuss registration applications and pricing of a number of new drugs, the re-pricing of a number of other registered medicines, as well as to review the availability of some medicines in the Omani drug market.
The Committee approved applications for the registration of 36 new medicines following the fulfillment of all the conditions and procedures stipulated in implementing the pharmacy practice and pharmaceutical institutions law. Conditions outlined the scientific evaluation of the contents and uses of these drugs, as well as the evaluation of bioequivalence studies for some of them, in addition to conducting chemical, physical and biological analyses to ensure that they conform to the standard specifications.
Furthermore, the Committee approved the prices of the drugs. It agreed to the prices of three drugs provided by companies because of the drug market need and the lack of alternatives. It further adopted lower prices than those presented by the manufacturers of about 29 medicines after reviewing and comparing the prices provided to Oman with those of other countries such as the Gulf Cooperation Council countries.
The Committee postponed the registration of four drugs to request new price certificates from companies.
During the meeting, the Committee reviewed the prices of six innovative drugs from a number of international companies, and decided to reduce the prices of these drugs, in addition to reducing the prices of 13 generic drugs in line with the reduction of innovative drugs, which are the main reference for their prices.
Moreover, the Committee agreed to re-register 86 medicines and review their prices as the re-registration and reduction of the prices of 20 medicines, and the re-registration of the rest of the drugs were approved while maintaining the same previously recorded prices.