<\/p>\n
On 31 October, the Health Care Committee of the European Business Association held a working meeting with representatives of the State Expert Centre (SEC) of the Ministry of Health of Ukraine. Issues of regulatory predictability and alignment of national procedures with European approaches traditionally remain among the top priorities for the pharmaceutical industry. During the meeting, participants exchanged views and agreed on several strategic directions for further cooperation.<\/p>\n
One of the topics discussed concerned the updated EU approaches to the classification of variations, including Type IA, and possible ways of implementing these changes into Ukrainian legislation. The SEC experts shared their vision, expressed readiness to adopt new approaches, and proposed to continue discussions in an extended format involving experts from the Ministry of Health, the State Service of Ukraine on Medicines and Drugs Control, the SEC, and the EBA, as such significant changes require additional consultations and coordination.<\/p>\n
Participants also discussed organisational challenges in registration procedures, particularly during the preliminary and specialised examination stages, ways to improve interaction and information exchange between applicants and the SEC\u2019s Legal Department, as well as possible operational solutions. Following the discussion, the parties agreed to strengthen the industry\u2019s consultative support and to conduct more detailed training sessions for applicants.<\/p>\n
In addition, SEC experts provided clarifications regarding references to pharmacopoeias in finished medicinal product specifications (especially when using in-house methods) and offered recommendations on the appropriate format for submitting this information.<\/p>\n
The SEC representatives also announced further development of the eCTD system. Active work is currently underway to introduce functionality for submitting Periodic Safety Update Reports in this format. The Centre plans to launch a pilot project next year to test this new feature. In connection with these updates, a revised version of the eCTD Specification and Validation Criteria is expected to be released soon. The update will not only include the new functionality but also correct previously identified errors.<\/p>\n
Finally, special attention was given to issues requiring further detailed consideration and coordination in order to harmonise approaches and increase the transparency of regulatory procedures. The EBA Health Care Committee sincerely thanks the colleagues from the State Expert Centre for their openness and constructive dialogue.<\/p>\n
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On 31 October, the Health Care Committee of the European Business Association held a working meeting with representatives of the State Expert Centre (SEC) of the Ministry of Health of Ukraine. Issues of regulatory predictability and alignment of national procedures with European approaches traditionally remain among the top priorities for the pharmaceutical industry. During the […]<\/p>\n","protected":false},"author":33544,"featured_media":687955,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[4,5,22],"tags":[],"yoast_head":"\n