Regulatory Variation Submission Challenges for Vaccines in Emerging Countries

CHALLENGE

Because the processes for submitting variations to vaccine regulatory dossiers can differ from country to country, a consulting firm's Big Pharma client wanted more information about the pre-submission process for variations, the decision-making process of regulators, and the practices of health authorities and competitors in Turkey, Mexico, South Korea, India and Vietnam.

BTHT APPROACH

BTHT examined the health authorities; ministries of health and regulatory agencies of the requested countries, in a short time and contacted the experts in the relevant units. The team also reached out to experts who had former agency experience and are currently working as consultants or academics. The sourced experts with current or past experience in regulatory units in the agency included:

• Executive director
• Advisor to the head of the agency
• Scientific variation committee member
• Regulatory officials
• Registration specialists
• Technical advisors for submissions
• Quality assessor for variation applications
• Drug inspectors
• Reviewers who can explain the regulatory authority side of the vaccine variation process, the main expectations in receiving a variation application, best practices for pharmaceutical companies to reach the submission approval and reasons for rejection of variation submissions.

In addition, BTHT team also connected with professionals from competitors (pharmaceutical companies / vaccine manufacturers) experienced in current vaccine regulatory approval and submission process, simultaneously with expert research in regulatory agencies. These local and global industry experts are consisted of :

• Senior executives
• Director/Head of Regulatory Affairs, Quality and Government Affairs
• Regulatory affairs consultants and key opinion leaders, who can clarify different approaches for submission approval, regulatory challenges, health authorities expectations and previous examples.

Consultations were arranged by BTHT team in the form of 1-hour interviews. Technical assistance was provided to experts and clients to avoid any problem in the interviews.

OUTCOME

BTHT's bringing experts together from both regulatory health authorities and competitors with the client in a short time allowed the client to understand both the regulatory side and the industry side of the variation submission process, as well as what needs to be done before, during and after the submission, the expectations of the authorities and the challenges experienced by the industry. Also concrete examples and case studies provided by the experts helped the client better analyze the submission process of different countries.