On 21 July 2020, the new procedure for confirming good manufacturing practice (GMP) compliance became effective.
The new procedure for confirming GMP compliance was approved by the Order of the MOH No. 1346 'On Approval of the Procedure for Confirming Compliance of Pharmaceuticals Manufacturing with Good Manufacturing Practice' dated 9 June 2020 (Procedure).
Among other things, the Procedure provides for the following:
- Narrowing down the list of authorities the GMP certificates/manufacturing licenses of which are recognized in Ukraine for the purpose of expedited GMP confirmation (i.e., without on-site inspection). Previously, Ukraine recognized GMP certificates issued by authorities that are members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). From now on, for the purpose of the expedited GMP confirmation, Ukraine only recognizes GMP certificates/manufacturing licenses issued by the authorities in the EU, UK, US or a country that has a mutual recognition agreement with Ukraine or the EU.
- Extending the list of documents that must be submitted for the purpose of confirming GMP compliance (e.g., the revised list includes copies of the certificate of a pharmaceutical product and marketing authorization issued in EU member states, UK or other countries that have a mutual recognition agreement with the EU or Ukraine).
- Introducing remote inspections that may be conducted in a number of cases, including pandemics.
- Establishing risk assessment criteria for planning the duration and scope of inspections.
In addition, the State Service of Ukraine on Pharmaceuticals and Control of Narcotics published a note on its website stating, for the purpose of reviewing the applications for confirming GMP compliance, including for inspection of manufacturing facilities, the State Service of Ukraine on Pharmaceuticals and Control of Narcotics will engage state enterprises that provide services on a paid basis. However, neither the Procedure nor other relevant regulations offer for the possibility of engaging the state enterprises for providing paid services in relation to confirming GMP compliance. It is expected that the State Service of Ukraine on Pharmaceuticals and Control of Narcotics will develop the necessary regulations that permit the engagement of third parties in the review and inspection procedures.
The above developments provide for more complex rules and procedures for confirming GMP compliance in Ukraine and may result in increased costs and timelines for obtaining conclusions/certificates of GMP compliance.
For more information, please contact Olha Demianiuk of our Kyiv office.
Updated guidance on conduct of clinical trials in view of the spread of COVID-19
The regulator for clinical trials, the State Expert Center of the Ministry of Health of Ukraine, on 14 September 2020 issued updated recommendations regarding conducting clinical trials in view of the spread of COVID-19, which are based on guidance on the management of clinical trials during the COVID-19 (coronavirus) pandemic issued by the European Medicines Agency, Version 3, 28 April 2020.
Among other things, the State Expert Center noted that sponsors, sites and investigators need to consider the following additional measures (subject to compliance with certain restrictions):
- identifying, assessing and documenting in the protocol and other clinical trial materials the additional risks connected with the spread of COVID-19 and risk-mitigating measures;
- transferring, in exceptional circumstances, study subjects to other sites;
- reporting on online safety;
- obtaining informed consent remotely by signing separate forms by the study subject and the investigator (in case of COVID-19 study subjects);
- providing study subjects with greater quantities of investigational products;
- rearranging the distribution of investigational products between different sites;
- canceling or postponing on-site monitoring or using centralized, off-site monitoring or remote source data verification and
- postponing sponsor audits