KYIV. April 14 (Interfax-Ukraine) – The Health Ministry of Ukraine has initiated a new procedure on registering drugs and a separate procedure on drugs registered under the relaxed procedure, First Deputy Health Minister Oleksandra Pavlenko has told Interfax-Ukraine.
“In 2014, amendments to the law on drugs were passed and they introduced a relaxed procedure on registering drugs to treat tuberculosis, HIV/AIDS, cancer and orphan diseases which were registered in the country with the tough regulatory system. In addition, the law foresaw the limitless registration of drugs after their re-registration. The realization of the requirements [was] delayed, as resolution No. 376 that activates [this policy] was not passed for a long period of time. When we came to the Health Ministry, the resolution was not passed,” she said.
Pavlenko said that when the amendments were drawn up with representatives of pharmaceutical companies the Health Ministry realized that the revised procedure should be approved.
She said that the new procedure will foresee the submission of applications to register drugs directly with the state expert center of the Health Ministry.
Pavlenko said that the Health Ministry will present the draft procedure approved by representatives of pharmaceutical companies for those categories of drugs to which the relaxed procedure will apply.
“We’ve created a separate procedure for checking the materials,” she said.
She also said that the Health Ministry will present the regulations on relations between the Health Ministry and the state expert center when a decision of the Health Ministry on conducting clinical tests has been prepared.
Pavlenko added that the ministry has agreed a list of vitally important drugs covered by state procurement, utilizing budget funds, with international organizations, in particular, the WHO.