Vaccine manufacturers and regulators complete training on CTD format and requirements for vaccine dossiers to improve access

The Local Production & Assistance (LPA) Unit in the Regulation and Prequalification Department, WHO, successfully completed training of about 800 vaccine manufacturers and regulators from over 60 countries in the six WHO regions on the format and documentary requirements of a vaccine dossier for a WHO prequalification (PQ) and Emergency Use Listing (EUL) application.

One cause for delays in timely registration and access to vaccines, particularly in low- and middle-income countries (LMICs), is submitting incomplete vaccine dossiers to regulators. The Virtual Training Workshop on the Documentation Format Requirements and Principles of Assessment for the WHO Prequalification and Emergency Use Listing of Vaccines, organized by the Local Production and Assistance Unit from 28 June to 1 July 2022, built the manufacturers’ and regulators’ understanding, particularly in LMICs, on the common technical document (CTD) format and quality requirements for vaccines as described in the guidelines of WHO for PQ/EUL and other regulatory authorities for registration.

This workshop comes at a timely moment when efforts in strengthening local production of quality, safe and effective routine and COVID-19 vaccines continue to ramp up globally. Manufacturers and regulators in many LMICs around the world seek training in CTD format and quality requirements for vaccines to prepare themselves for improving timely registration and access once these vaccines are produced. For ~25% of the participants, this workshop continues their capacity building, having completed the second Virtual cGMP Training Marathon for Vaccine Manufacturing organized by the LPA Unit last October and November.

What participants had to say:

“This is a very good initiative by the Local Production and Assistance Unit. I have participated in three marathons / workshops including the pharmaceutical manufacturing, vaccine manufacturing and the current Documentation Format Requirements and Principles of Assessment for the WHO Prequalification and Emergency Use Listing of Vaccines. All these trainings have had a great impact on my understanding of the cGMP, cGLP, cGCP and facility upkeep requirements. Kudos to Dr. Jicui Dong and the LPA staff for this as this would improve the global quality of pharmaceuticals.” – Muhammad Tahir Iqbal, Associate Director Engineering & Projects, BF Biosciences Limited, Pakistan

“The LPA Unit is playing a pivotal role in the capacity building of developing countries and paves the way to share vast experiences around the world.” – Theodros Fenta Ibrahim, Medicine Assessor, Ethiopian Food and Drug Authority, Ethiopia

“Great initiative of WHO which will be helpful all the vaccine manufacturers around the globe.” – Zebun Nahar, Manager, Incepta Vaccine Ltd, Bangladesh

“The training workshop was really impactful. I sincerely appreciate the organizers for this gesture and look forward for more of this to enhance my performance on the job. This training will no doubt enhance my professionalism and also make me to handle some issues more technically.” – Terwanger Philip Tarhemba, Principal Regulatory Officer, National Agency for Food and Drug Administration and Control, Nigeria

“This workshop highlights the importance of each modules in CTD and helps us prepare and evaluate the documents before submission. The case study is helpful and interesting.” – Suttida Puksuriwong, Researcher, Government Pharmaceutical Organization, Thailand

“It is very useful for my work and I hope that in the future will have more and more workshops like this, thank you so much.” – Ha Trinh Thi, Quality Control Dept., Vabiotech, Vietnam

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