The Move Toward Global Standards: Navigating New EAEU Guidelines
As the pandemic clearly revealed, there is an urgent need for a more cohesive, coordinated approach to streamline global regulatory guidelines to ensure patients have faster access to new and innovative drugs. Coincidentally, the height of the global pandemic coincided with the start of a new chapter in my career journey, one that would allow me to support our clients in the implementation of new requirements for the Eurasian Economic Union (EAEU), an economic union of countries in Eastern European, Central and Western Asia.
These new requirements allow for the five member states to operate a national medicines market in a single space, and to apply for registration of medicines and their release in all five markets simultaneously under common procedures and reduced administrative costs.
Coming to Parexel at this critical juncture has provided me the opportunity to assist our clients in navigating the new guidelines for those who are seeking to enter the EAEU market, where I have spent the past two years supporting customers in Russia, Ukraine and Belarus with dossier compilation and submission.
Defining the Need: EAEU History
The EAEU was established to encourage the free movement of goods and services as well as the potential for creating a single currency in the future. In May of 2017, three years after the EAEU treaty was signed, the EAEU countries ratified the regulatory framework for a common market for medicines, creating a set of 26 documents to be gradually implemented across all countries and fully adopted by 2025. The guidelines are based the following principles and are designed to loosely align with EU guidelines:
- Harmonization and unification of the requirements of the law of the member states
- Ensuring the unity of mandatory requirements for the quality and safety of drugs in circulation on the territory of the EAEU
- Adoption of uniform rules in the field of drug circulation;
- Development and application of the same and comparable research and control methods
- Harmonization of the legislation of the member states in the field of control (supervision) of drug circulation
- Implementation of the process for development, clinical and non-clinical studies, market authorization, manufacture, sale, advertising, transportation, advertising, destruction, etc., medicinal products by the authorized institutions of member states.
Establishing a Consistent EAEU and EU framework
The more consistent the global standards, the more expedient the approval of new medications within larger geographic regions.
In 2017, the Ministry of Technical Regulation of the EAEU and the leadership of European Directorate for the Quality of Medicines (EDQM) convened to discuss the creation of a unified pharmacopeia in EAEU and EU countries. In early 2019, a unified electronic drug labelling guideline was introduced to allow for tracking and greater transparency into the origin of a particular batch of medicine or medical device to further optimize quality and enhance safety for patients.
The common set of guidelines is designed to reduce the complexity and administrative burden on the pharmaceutical industry; to expand member countries’ access to new products; to enhance product quality; and to reduce administrative costs and prices for essential medicines for patients.
Implementing this regulation has required significant time and resources among member states, in particular the Russian Federation, as there are considerable differences between the respective regulations of each member nation.
Moreover, there are set timelines for abiding by the new regulations that will influence market access and product marketing going forward. On Dec. 31 of 2020, the national requirements for submission process will be replaced by Decentralized Procedure (DCP)/ Mutual Recognition Procedure (MRP).
In order to remain on the EAEU market, it is mandatory that all the medicinal products authorized prior to this date follow the harmonization process for the EAEU regulation until December 31, 2025.
EAEU Initial Implementation Requirements
The advantages of Electronic Common Technical Documents (eCTD) are well established, including greater efficiency and shorter timelines for dossier analysis. However, eCTD adoption been slower in some parts of the world than others, including in the EAEU, where submission of medicines dossiers continues to be done by paper and CD. Recently, Russian-speaking countries have begun to align their manufacturing sites with international standards, including approving international pharmacopeias using E.U. and U.S. guidelines as their standard. The move to eCTD is critical for manufacturers who want to be competitive in this global market.
Preparing for EAEU Electronic submission
Among the new EAEU requirements is to provide the electronic dossier in a particular format of the XML (R.022, instead of the known format R.017). This second XML version contains information on the documents submitted, together with specific identifiers for each document type. To help customers adapt to these new standards, Parexel is working closely to provide detailed guidance, including:
- Publishing updated EAEU Best Practices and User Alert for EAEU, which include the EAEU template with all recent amendments and the appropriate dossier structure with mandatory codes
- Our proprietary Insight Publisher software to support EAEU regulatory updates and create compliant submissions
Support and Consultation
Parexel’s regulatory submissions and publishing team has extensive global experience in EAEU countries to ensure that submissions are streamlined and as consistent as possible across the globe. We provide:
- Published guidance documents for step-by-step adherence to procedures and processes
- Expert consultation to navigate the complexities and nuances of EAEU amendments
- Accurate translation of documents in each language to ensure clarity and accuracy
- Dossier submission by CD until an EAEU electronic gateway is established
Global Regulatory Alignment Expands Global Patient Access
As patient demand for new drugs continues to rise, health authorities in each region of the world are recognizing the need to align their respective practices and procedures to ensure their residents have rapid access to the latest therapies. Toward this end, health agencies in some emerging markets are now open to and accepting other regions’ approvals, recognizing that the rigorous review process in the U.S. and Europe, for example, are sufficient for approval in their own countries. As one example, sponsors can now make parallel applications to the FDA and EMA for orphan drug designation via a single common form. As the EAEU continues to adapt its guidelines to expedite the drug development process, sponsors will increasingly view this region as an attractive market for pursuing clinical research opportunities.