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Global Quality Regulatory Maze Jeopardizes Vaccine Supply, IFPMA is Stressing

Feb 23rd, 2014

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The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) is throwing a spotlight on the impact that the current tangled global regulatory web is having on the ability to supply vaccines to the people who need them.

Significant obstacles for vaccine manufacturers in meeting the global need, IFPMA is stressing, include: ● the complexities, disharmonies and extended timelines for clearance of marketing applications and post-approval changes around the world ● the need for transferring high-tech processes to meet localized production requirements, and ● the time required for redundant regulatory lot clearance.

The effort by the global non-profit, non-governmental organization (NGO) to create broader awareness around these problems in the vaccine arena reflects IFPMA’s mission to “advocate for policies that encourage discovery of and access to life-saving and life-helping medicines to improve the health of people everywhere.”

IFPMA has published a brochure explaining the significant role vaccines play in global health and the obstacles that the current disparate regulatory processes place in the way of their availability, and the organization is adding its voice at public forums to the call for an international effort to find a harmonized pathway forward.

Speaking for IFPMA at the final plenary session of the CASSS/FDA WCBP Symposium in late January in Washington, D.C., Merck Biologics VP and Biologics/Vaccines Regulatory CMC Executive Director David Robinson stressed that, “new, increasingly complex vaccines, high quality standards, and the volatile regulatory environment are combining to create what is an essentially non-sustainable situation. In order to sustain access to vaccines, the regulatory environment does need to adapt.”

The final plenary WCBP session was focused on the challenges of managing the global quality regulatory complexities that biotech products face.

Along with Robinson’s, compelling presentations on the post-approval change dimension of the problem were made by Bristol-Myers Squibb (BMS) Global Regulatory Sciences CMC Executive Director Annie Sturgess and Roche Head of Marketed Biologics for the EU Ralf Gleixner.  Both shed a hard light on the quagmire that global manufacturers, and biotech producers in particular, face in trying to make process improvements.

The post-approval change concerns also drew front-burner attention at the CMC strategy forum Japan held in Tokyo in December, which focused on problems in Japan’s post-approval change system, including a lack of flexibility around biopharmaceutial manufacturing changes that results in most requiring prior approval as well as meetings with the agency to resolve unclear expectations (IPQ February 6, 2014).  Presentations were given there by a Japanese reviewing official as well as by a JPMA representative and an Amgen executive that compared Japan’s system to the rest of the world.

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See related IPQ stories:

International Panel of Regulators Spotlights Current Biotech CMC Regulatory Problems and Convergence Pathways

Post-Approval Change Regulatory Burden Draws Heat at Japan Biotech CMC Strategy Forum

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