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Procedure for simplified registration of drugs registered in countries with stringent regulatory system not effective – IPMA
KYIV. Feb 17 (Interfax-Ukraine) – The procedure for simplified registration of medicines registered in countries with a stringent regulatory system, provided for by Health Ministry order No. 1245 issued in 2016, is not effective, according to the Indian Pharmaceutical Manufacturers Association (IPMA).
“The simplified procedure provided for the registration of medicines registered in countries with a stringent regulatory system has recently been ineffective, and applicants have been denied on formal grounds,” the IPMA said.
According to the association, in particular, based on the conclusion of the State Expert Center (SEC), the Ministry of Health appointed a meeting of the commission on problematic issues, where a collegial decision was made regarding registration, but since February 2022 no meeting of the commission has been held. At the end of 2022, nevertheless, orders were signed on the state registration of medicines registered by the competent authorities of the United States, Switzerland, Australia, Canada, and the EU. At the same time, on February 10, 2023, the Ministry of Health signed an order to refuse state registration of 34 foreign-made medicines.
“We believe that the simplified procedure would work more effectively if the work of the commission of the Ministry of Health of Ukraine on problematic issues resumed. Refusal to register 34 drugs from leading foreign manufacturers due to problems in the interpretation of legislation and on a formal basis is discriminatory and damages the well-being and health of the Ukrainian people in wartime,” the IPMA said.
The association believes that the order dated February 10, 2023, which denied the registration of 34 drugs registered in countries with a stringent regulatory system, should be canceled, and the applicants who fell into this order and received an opportunity to justify the existence of grounds for registration and confirm compliance with the law.
IPMA said that the reason for the refusal to register drugs, the applicants of which are IPMA member companies, could be inconsistencies, partly due to legal requirements and the peculiarities of registration in Ukraine.
“This is the first registration of medicines manufactured in India, the applicants of which are members of our Association. These are new high-quality medicines that have already passed the peer review of the competent authorities of the United States, Switzerland, Japan, Australia, Canada and registered by the competent authority of the EU under the centralized procedure,” the IPMA said.
The association said that not all analogues of drugs, the registration of which was refused, are currently on the market, but there are new drugs on this list.
“For example, medicines of one of the applicants (Zandra Life Sciences Private Limited), submitted for registration under this procedure, are new generic medicines that have no analogues in Ukraine but have already been successfully registered and used in the United States. Their registration in Ukraine will allow Ukrainian patients to use them in treatment,” the IPMA said.