In 2023, the State Expert Center of the MoH (hereinafter – the Center) conducted 17 (seventeen) targeted audits of applicants’ pharmacovigilance systems in order to examine in detail the processes, decision-making, information exchange, and activities related to the specific reason that triggered such an audit.
In 2023, 4 (four) audit schedules were published on the Center's official website to notify applicants of planned inspections.
All inspections were conducted remotely using computer programs for online communication, which made it possible for both the manufacturing site and the applicant's head office to be present simultaneously in a conference call with the Center's audit team, as well as third parties, while guaranteeing the safety of all personnel involved under martial law in Ukraine.
The types of non-conformities identified during inspections were classified, in accordance with the requirements of the Pharmacovigilance Procedure, as critical (hereinafter – CN), major (hereinafter – MN) and minor (hereinafter – mN).
Audits were conducted at 6 (six) applicants whose main pharmacovigilance activities are carried out in Ukraine and at 11 (eleven) outside Ukraine.
During the reporting period (2023), 5 critical, 79 major, and 21 minor non-conformities were identified.
Fig.1. Number of non-conformities identified in 2023
During the reporting period, 5 (five) critical non-conformities were identified as a result of targeted audits conducted at 3 (three) applicants. The identified critical non-conformities concerned the following processes:
- documentary confirmation of the delegation of pharmacovigilance activities in Ukraine;
- maintaining and updating the Applicant's pharmacovigilance system master file;
- planning, preparation, submission and evaluation of periodic safety update reports;
- updating information on medicinal products on safety and pharmacovigilance issues.
Відповідно до вимог Порядку здійснення фармаконагляду 2 (два) заявники усунули критичні невідповідності протягом визначеного для усунення недоліків строку. Інформацію про ще 1 (одного) заявника, що не усунув протягом визначеного строку критичну невідповідність, подано до Міністерства охорони здоров’я України з пропозицією про тимчасову заборону застосування лікарських засобів шляхом припинення дії реєстраційних посвідчень.
Summary information on the distribution of inspection results by process type is presented in Figure 2.
Fig. 2. Distribution of inspection results by process type
The largest share of non-conformities concerned the pharmacovigilance system master file 21%; the authority, qualifications and substitution procedure of the qualified person/contact person for pharmacovigilance in Ukraine ‒ 19%; the quality system within the pharmacovigilance system ‒ 17%; delegation of pharmacovigilance activities in Ukraine ‒ 16%.
Центром було проаналізовано 53 (п’ятдесят три) версії Планів коригувальних та запобіжних заходів (далі – ПКЗЗ), які були надані заявниками до Центру для погодження протягом 2023 р. з метою усунення критичних та суттєвих невідповідностей, виявлених під час проведених аудитів. З них погоджено Центром 10 (десять) ПКЗЗ як такі, що містять повну інформацію щодо коригувальних та запобіжних заходів. На інші версії Центром було надано рекомендації/зауваження щодо необхідності доопрацювати заплановані заходи задля повного комплексного усунення встановлених невідповідностей, а також, запобігання виникненню подібних невідповідностей у майбутньому.
In 2023, the Center received 8 (eight) reports on the status of implementation of corrective and preventive action plans (CAPA), confirming the elimination of non-conformities identified during audits through the implementation of corrective and preventive measures.
Achievements of the Applicants' Pharmacovigilance System Audit Division for 2023
- The number of audits conducted has doubled compared with the same period of 2022.
- Participated in international training seminars, including the online training “EMA pharmacovigilance inspections: the role of the EMA and national regulatory authorities.”
- Took part in the pharmaceutical forum PHARMA@FOCUS ON THE PATIENT (26.04.2023) with a presentation on the topic "Audit of the applicant's pharmacovigilance system. Specifics of conducting an audit during martial law."
- Consultations were provided to applicants/applicants' representatives (by prior appointment, using computer programs for online communication, telephone consultations, etc.) on audit issues and post-audit measures.
- Training seminars for applicants were held on the following topics:
- Targeted audit of applicants' pharmacovigilance systems (26.06.2023)
- The most common non-conformities identified during the audit of applicants' pharmacovigilance systems. An example of developing a Corrective and Preventive Action Plan (20.09.2023; 07.11.2023).
Current trends and development prospects
- Holding training seminars for applicants
- Participation in the pharmaceutical forum with international participation “PHARMA@PATIENT FOCUS 2024. PHARMACOVIGILANCE”
- Updating internal regulatory documentation
- Review of current regulatory legal acts with a view to updating and harmonizing them with European standards
- Learning from the experience of the EMA pharmacovigilance inspections working group
The Department for Audit of Applicants' Pharmacovigilance Systems makes its contribution to the national pharmacovigilance system and, as a structural unit of the Center, takes part in laying the foundation for the further growth and development of Ukraine's pharmaceutical sector.
