Recommendation of the Board of the Eurasian Economic Commission No. 11 dated June 8, 2021, "On the Guidelines for the Transfer of Technology and (or) Analytical Methods in the Manufacture of Medicines" takes effect on December 10, 2021.

The Guidelines outline operational instructions for pharmaceutical manufacturers, testing laboratories, pharmaceutical inspectorates, and expert organizations of the EAEU member states regarding the measures required to successfully execute technology and/or analytical method transfers between business units within a single manufacturing site, across multiple manufacturing sites, or among testing laboratories.

The overarching objective of technology transfer is to transmit information concerning a medicinal product, its manufacturing process, and quality control mechanisms within a single manufacturing site or between different facilities. This includes transferring pharmaceutical development data into commercial production, as well as transferring analytical methodologies from a manufacturing site to an accredited testing laboratory.

Technology transfer entails the systematic transmission of any process, accompanied by corresponding documentation and professional expertise, from the sending party to the receiving party. This structured, standardized procedure ensures that the documented information and experience acquired during pharmaceutical development are successfully handed over to the receiving entity.

The Guidelines establish the following core stages of the transfer process:

• Planning, organization, and project management;
• Establishing explicit transfer success criteria;
• Assembling a dedicated project team;
• Consolidating knowledge and performing a thorough gap analysis;
• Identifying key skill sets and conducting personnel training (where applicable);
• Executing data analysis and quality risk assessments;
• Drafting the formal technology transfer protocol;
• Qualifying manufacturing facilities, equipment, and utility systems (where applicable);
• Transferring analytical methodologies either within the scope of technology transfer or as a standalone process (where applicable);
• Manufacturing pilot, scale-up, and/or engineering batches;
• Validating the commercial manufacturing process;
• Executing stringent cleaning validation procedures;
• Documenting final results and evaluating transfer efficiency based on the achievement of established success criteria.

Because not all outlined stages apply to every type of transfer, manufacturers may selectively implement the specific steps relevant to their particular procedure.

The primary participants in a technology transfer are the sending party and the receiving party. When necessary, companies may designate a coordinating party to act as an independent process administrator. For contract manufacturing transfers, stakeholders must comply with the Good Manufacturing Practice (GMP) Rules.

To ensure a successful technology transfer, operations must satisfy the following stringent requirements:

• Controlling all quality aspects concerning pharmaceutical manufacturing throughout the transfer process;
• Basing the transfer strategy firmly on quality risk management principles;
• Ensuring the sending and receiving parties possess comparable—though not necessarily identical—technical capabilities, and that both operate facilities and equipment under uniform operational principles;
• Incorporating comprehensive technical risk assessments and identifying potential regulatory compliance deviations during the gap analysis between the parties;
• Appropriately training and qualifying the receiving party’s personnel at the sending and/or receiving facilities in strict alignment with the transfer plan;
• Consistently interpreting and accounting for the regulatory requirements of competent authorities in the host countries of both parties, as well as third-party jurisdictions targeted for product supply;
• Executing an effective, documented transfer of processes, technical skills, and advanced medicinal product knowledge.

Additionally, the Guidelines provide standardized document templates, including technology transfer protocols, analytical method transfer protocols, and transfer reporting forms.

The Eurasian Economic Commission recommends that EAEU member states apply these Guidelines upon the expiry of six months from their publication date (the document was published on the official EAEU website on June 10, 2021).