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Business calls for a comprehensive change in the GMP verification procedure in Ukraine

10/ 11/ 2020
  According to the member companies of the EBA Health Care Committee, the process of confirming the requirements of good manufacturing practice (GMP) in Ukraine has recently deteriorated. Unfortunately, this situation is due, first of all, to the lack of positive changes in the institutional capacity of the State Service of Ukraine on Medicines and Drug Control in recent years. Secondly, the imperfection of the GMP confirmation procedure in Ukraine is also a part of the reason. The experts of the EBA Health Care Committee consider that it is time to admit the existence of these problems. Sporadic changes in the regulation of the GMP confirmation procedure in Ukraine are not effective. There is still an accumulation of problems that deepen and lead to a dead end. Given the real resources of the State Service of Ukraine on Medicines and Drug Control, the EBA experts propose a strategic approach to the GMP certification in Ukraine. In particular, the recently announced work on a new version of the Law of Ukraine On Medicines is an opportunity to change the situation. The current conditions for the certification of EU GMP certificates need to be simplified and improved, which should be considered when drafting a new version of the regulation. At the same time, the move towards mutual recognition of GMPs under the ACAA Agreement should also be included as a strategic, albeit an apparently long-term, area of ​​work. Such proposals are due to flaws in the legislation and procedural delays in the State Service of Ukraine on Medicines and Drug Control, which often prolongs the overall period of receipt of GMP Conclusions by manufacturers. Delays are critical from time to time, as, without a valid GMP Conclusion, drug imports and/or registrations are at risk. It is also worth noting that the forced restrictions on the work of foreign inspectorates and manufacturers due to the COVID-19 pandemic should to some extent free up the resources of the State Service of Ukraine on Medicines and Drug Control. Particularly, in connection with the pandemic, the EU has introduced an automatic extension of all GMP certificates until the end of 2021. This simplification was partially reflected in the work of the State Service of Ukraine on Medicines and Drug Control, making remote inspections of production possible. This should have slightly reduced the workload of the state inspectorate, but, unfortunately, manufacturers do not observe positive dynamics. For many years, despite the periodic updating of Ukraine’s GMP legislation, several issues related to the adaptation of Ukrainian legislation to EU norms remained unresolved. First, there is no solution to a situation where GMP certificates are automatically renewed in the EU without inspection. Secondly, the unresolved issue of the gap period when the literal validity of the GMP certificate expires but the next inspection is yet to be expected. In the EU, this situation does not affect the production and circulation of medicines, unlike in Ukraine. The absence of such provisions in the legislation makes it difficult for foreign manufacturers and importers of medicines to operate in Ukraine. The purpose and meaning of the GMP certification procedure need to be comprehensively reconsidered, as this procedure aims essentially to reconfirm the existing European original certificates. It is necessary to take into account the existence of a general complex of regulation of production and circulation of medicines in those countries for which Ukraine has already been confirmed the absence of the need for physical inspections of production. After all, such a decision was once made based on the generally recognized and confirmed a high level of national or supranational control in such countries. The EBA Committee Experts express readiness to take an active part in joint work with the Verkhovna Rada Committee on Public Health, Medical Assistance, and Medical Insurance, the Ministry of Health of Ukraine and the State Service of Ukraine on Medicines and Drug Control on a new version of the Law On Medicines aimed at tackling various problems of the pharmaceutical industry. We also hope to solve the problem with the procedure for verification of original GMP certificates of leading international manufacturers in Ukraine, which has a significant impact on the sustainability of the pharmaceutical business in Ukraine and providing Ukrainian citizens with the necessary quality treatment.   Be the first to learn about the latest EBA news with our Telegram-channel – EBAUkraine.

According to the member companies of the EBA Health Care Committee, the process of confirming the requirements of good manufacturing practice (GMP) in Ukraine has recently deteriorated. Unfortunately, this situation is due, first of all, to the lack of positive changes in the institutional capacity of the State Service of Ukraine on Medicines and Drug Control in recent years. Secondly, the imperfection of the GMP confirmation procedure in Ukraine is also a part of the reason.

The experts of the EBA Health Care Committee consider that it is time to admit the existence of these problems. Sporadic changes in the regulation of the GMP confirmation procedure in Ukraine are not effective. There is still an accumulation of problems that deepen and lead to a dead end.

Given the real resources of the State Service of Ukraine on Medicines and Drug Control, the EBA experts propose a strategic approach to the GMP certification in Ukraine. In particular, the recently announced work on a new version of the Law of Ukraine “On Medicines” is an opportunity to change the situation. The current conditions for the certification of EU GMP certificates need to be simplified and improved, which should be considered when drafting a new version of the regulation. At the same time, the move towards mutual recognition of GMPs under the ACAA Agreement should also be included as a strategic, albeit an apparently long-term, area of ​​work.

Such proposals are due to flaws in the legislation and procedural delays in the State Service of Ukraine on Medicines and Drug Control, which often prolongs the overall period of receipt of GMP Conclusions by manufacturers. Delays are critical from time to time, as, without a valid GMP Conclusion, drug imports and/or registrations are at risk.

It is also worth noting that the forced restrictions on the work of foreign inspectorates and manufacturers due to the COVID-19 pandemic should to some extent free up the resources of the State Service of Ukraine on Medicines and Drug Control. Particularly, in connection with the pandemic, the EU has introduced an automatic extension of all GMP certificates until the end of 2021. This simplification was partially reflected in the work of the State Service of Ukraine on Medicines and Drug Control, making remote inspections of production possible. This should have slightly reduced the workload of the state inspectorate, but, unfortunately, manufacturers do not observe positive dynamics.

For many years, despite the periodic updating of Ukraine’s GMP legislation, several issues related to the adaptation of Ukrainian legislation to EU norms remained unresolved. First, there is no solution to a situation where GMP certificates are automatically renewed in the EU without inspection. Secondly, the unresolved issue of the “gap period” when the literal validity of the GMP certificate expires but the next inspection is yet to be expected. In the EU, this situation does not affect the production and circulation of medicines, unlike in Ukraine. The absence of such provisions in the legislation makes it difficult for foreign manufacturers and importers of medicines to operate in Ukraine.

The purpose and meaning of the GMP certification procedure need to be comprehensively reconsidered, as this procedure aims essentially to “reconfirm” the existing European original certificates. It is necessary to take into account the existence of a general complex of regulation of production and circulation of medicines in those countries for which Ukraine has already been confirmed the absence of the need for “physical” inspections of production. After all, such a decision was once made based on the generally recognized and confirmed a high level of national or supranational control in such countries.

The EBA Committee Experts express readiness to take an active part in joint work with the Verkhovna Rada Committee on Public Health, Medical Assistance, and Medical Insurance, the Ministry of Health of Ukraine and the State Service of Ukraine on Medicines and Drug Control on a new version of the Law “On Medicines” aimed at tackling various problems of the pharmaceutical industry. We also hope to solve the problem with the procedure for verification of original GMP certificates of leading international manufacturers in Ukraine, which has a significant impact on the sustainability of the pharmaceutical business in Ukraine and providing Ukrainian citizens with the necessary quality treatment.

 

Be the first to learn about the latest EBA news with our Telegram-channel EBAUkraine.

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