Pharmaceutical experts have outlined new ways of effective cooperation within the EAEU. The pandemic has expedited important decisions making in forming a single market
On a general basis
Participants of the panel discussion “Present and Future of the EAEU Countries Single Market Integration”, held as part of V All-Russian GMP Conference, described the latest changes, and outlined the tasks for the near future in the context of creating the EAEU Countries single market.
The issues of creating a single market and integration within the EAEU market have been considered since 2014, when during the meeting of the Supreme Eurasian Economic Council (SEEC) in Astana (Kazakhstan), the Presidents of Russia, Belarus and Kazakhstan signed the Treaty on the Eurasian Economic Union (EAEU).
It came into force on January 16, 2015 and as for today 5 countries have joined it- Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia. The main provisions of the Single Market were formulated in the Treaty on Common Principles and Rules for the medicines circulation, which was signed in 2014 and ratified in 2016. Over the past period, a lot of work has been done to create a regulatory framework of the Union, to introduce a single information system.
The moderator of the session, Senior Director of Regulatory Affairs & Healthcare Policy, Association of International Pharmaceutical Manufacturers (AIPM) Elena Popova noted that now the EAEU Member States have actually passed the first stage of the transition period. “At the threshold of 2020-2021 years, the EAEU Members are already introducing Eurasian procedures in an effort to harmonize national legislation with supranational one, – she said. – The COVID-19 pandemic has made adjustments, and new mechanisms must be developed to meet the challenges of the time”. The expert also expressed the general positive opinion of the market participants regarding the recent changes in Russian legislation in connection with the transition to Eurasian procedures in the field of inspections of manufacture.
Integration is a complicated process that requires meeting certain deadlines. Documents of the second and third level had to be accepted before the beginning of 2021 for the procedures to operate in the most comfortable mode for the pharmaceutical industry. This was reminded by Alexey Alekhin, Director of the Department for pharmaceutical and medical industry development of the Ministry of Industry and Trade of the Russian Federation. Extensive work is being conducted to amend the legislation in order to bring it in line with the EAEU requirements.
On September 4 this year, the Eurasian Economic Commission (EEC) Council extended the Provisions of the Commission Council’s Decision as of November 3, 2016 No. 93 “On recognition of the inspections results of medicines manufacturing”. This document, within the transitional period from January 1, 2021 to December 31, 2025, establishes mutual recognition within the national registration:
- National GMP certificates of the EAEU Member States,
- The EAEU GMP certificates when making changes to the registration dossier and extension of national registration certificates for medicines manufactured in the EAEU,
- At national registration of the EAEU GMP certificates for medicines manufactured in third countries.
Decree of the Russian Federation Government as of September 5, 2020 No.1361 “On Amendments to the Rules of organization and inspection of medicines manufacturers for compliance with the requirements of GMP rules, as well as issuance of certificates for medicines manufacturers on the compliance with these requirements” suggests the development and adoption of a number of regulatory documents of the Ministry of Industry and Trade of the Russian Federation.
An important novelty is that the Ministry of Industry and Trade of the Russian Federation has been granted the status of the authorized organization for the implementation of the EEC Council decision (Decree of the Russian Federation Government No. 1446 as of September 15, 2020). In accordance with this status, the Administrative Regulations1 for the provision of public service in order to issue certificates for medicines manufacturers on their compliance with the requirements of the EAEU GMP rules were developed. This Decree allows the industry to apply for inspection for the EAEU GMP rules compliance in the Russian Federation.
A distinctive feature of 2020 was the transition to remote inspections. On September 18, SID&GP held 184 of such events. “Transition to a remote format of inspections allowed not to stop the process, but to some extent even to facilitate access to the Russian pharmaceutical market, which was positively welcomed by the industry, – highlighted Aleksey Alekhin. – We understand that this is not a permanent measure, but at the same time, we see positive responses to the actions that we are taking together with the “State Institute of Drugs and Good Practices”. We still have a long way to go in the integration processes. One of the milestones at the stage of establishing a single market and regulation should be the adoption of a federal law, the draft of which is currently being discussed as part of the regulatory guillotine. On the one hand, this has lengthened the approval process, but on the other hand, we will get a sharpened draft as the output, taking into account the opinions of all experts of the professional community who participate in working groups.
Integration issues are not only a single market for the EAEU, but also an accession into PIC/S. The most important task for the integration is interaction with international institutions. This includes, in particular, the issue of Russia’s accession into PIC/S (Pharmaceutical Inspection Co-operation Scheme). In 2017, the Ministry of Industry and Trade of the Russian Federation and SID&GP submitted a preliminary application to access in the organization, and at 2019 year-end, it was positively evaluated by the Committee of PIC/S officials, which gives our country the opportunity to become a full member of the organization.
Currently, an application for such status is being developed. This was described by Tatiana Nikolko, Deputy Head of Pharmaceutical Production Inspection and Expertise Administration, SID&GP. PIC/S unites national inspection services in the field of control on compliance with Good Practices, and gives its members the opportunity to participate in the development of standards, expand the exchange of experiences and export opportunities.
What is the manufacturers’ concern on the way of approaching the single market of the EAEU?
1. Inspections and marking
In the course of the panel discussion, the practical experience of regulatory practices and inspections on the way to create the EAEU single market were shared by representatives of the EEC, inspectorates of the Union’s member countries, as well as manufacturers. Quality Director for Russia and Eurasia of Teva Company, Margarita Mustafina emphasized that industry participants should develop an integrated pattern of behavior in terms of GMP-inspections, common approaches of the formation of registration dossiers, package layouts, package inserts. In the meantime, according to the speaker, the issue of medicines digital marking remains as a particular area of concern, and in this area, a number of steps should be taken to harmonize in accordance with the unified requirements. “For effective interaction in the Eurasian market in the implementation of medicines marking requirements, it is necessary to develop within the EEC the unity of the introduced requirements for identification means, as well as the unity of requirements for traceability of data and transfer of data into the system,” – stated the Quality Director of Teva Company. All this must be done now so that the industry is ready for a full transition to a single market in the very near future.
2. Inspections and medicines registration
Natalia Volovich, Deputy Director, Head of Registration Department of the Gedeon Richter Representative Office in Moscow, presented her vision of the situation. She noted that the plant in Egoryevsk manufactures the company’s products not only for the Russian market, but also for all of the EAEU countries. Therefore, the formation of the Eurasian Economic Union and the general regulatory environment for the company is a huge advantage, allowing to have one registration dossier, to carry out one inspection and, accordingly, not to have any additional requirements from other EAEU Member States.
“When the GMP-inspections by national requirements began, we realized that in each of the five countries the registration dossier is different, because each of the EAEU countries has its own pharmacopoeia, has its own regulatory requirements, – she highlighted. – But now all countries, as we notice, change regulatory requirements very quickly – they become more harmonious and closer to the Eurasian requirements”.
“In addition, the differences in pharmacopoeias and the recent publication that will soon be the official edition of the first volume of the Eurasian Union pharmacopoeia for us, on the one hand, is a great relief, on the other hand, it is a new challenge for the manufacturer, – added Volovich. – That is, in order to preserve the medicines familiar to doctors and patients, to obtain marketing authorizations, to manufacture and sell medicines in all of the EAEU markets, it is necessary to bring the dossier in line. EEC Decision No. 9 has a classification of changes that can be made by the manufacturer as part of the harmonization and which he must make before bringing the dossier in line. This is where we come across very interesting points, because in every country besides registration there is a control of circulation of medicines. For us, the question still remains, how will the quality of medicines be controlled? For example, if the reference country is the Russian Federation, where in the specification there is a reference to the Pharmacopoeia of the Russian Federation for quality control, how will national quality control be carried out when imported to Belarus, Kazakhstan, where its own pharmacopoeia operates?”.
Appealing to the information stated by the Deputy Head of the Coordination Division in the Sphere of Medicines and Medical devices circulation, Technical Regulation and Accreditation Department of the EEC, Anna Kravchuk, about the regulators’ consent to the extension of the use of national GMP certificates for Eurasian procedures and the possibility of applying for EEC inspection, the representative of Gedeon Richter urged manufacturers to be mobile when restructuring the strategy, which country to go with their applications in the first place by submitting new registers and bring dossiers in line. “We are one of the first companies that have submitted applications both in Belarus and Kazakhstan, – said Natalia Volovich, – We have gained our experience, we have already registered medicines according to the rules of the EAEU “.
Gedeon Richter also has experience in conducting Eurasian inspection, the certificate was issued by the Republic of Belarus. “Now, during the pandemic, there is no inspection of facilities in accordance to the rules of the EAEU and pending the extension of the transition period, when manufacturer can provide a national certificate for the EAEU-procedures, we change our strategy and prepare applications for inspection according to the GMP national requirements to the Ministry of Industry and Trade of the Russian Federation, – informed Natalia Volovich. – Online format of national inspections is, on the one hand, a big challenge for the company, not only for the employees of the plant, but also for those who provide documentary and technical support for the inspection. The new format, detailed work with manufacturer’s documents, the organization of urgent and competent translation of the inspection process and documentation, the quality of the Internet, technical capabilities of the site – these moments are also noted by our colleagues in the industry. But at the same time, there is a great advantage – not to stop the manufacturing processes, make the necessary changes to the registration dossier in time and, most importantly, initiate the registration of new medicines in the EAEU “.
The participants of the discussion agreed that the pandemic has served as a catalyst for making important decisions in the formation of the EAEU single market, forced regulators and manufacturers to join forces and to interact. In the near future, this movement will continue.
1. Order of the Ministry of Industry and Trade of the Russian Federation No. 2945 as of 04.09.2020 “On approval of the Administrative Regulations of the Ministry of Industry and Trade of the Russian Federation to provide public services for the issuance of GMP-certificates of the Eurasian Economic Union to manufacturers of medicines for human use “.
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- Russian Federation has submitted an application for the Pharmaceutical Inspection Co-operation Scheme PIC/S accession