Companies start work on 505 Pathway

newsJun 30, 2017 | Phorum : Drug Substance | News

A change in FDA regulations, associated with classification of proteins, prompted several companies to ask BPOG to facilitate a collaboration to help them to prepare.

By 2020, insulin products will be re-classified as biological products and approved as a BLA (Biologics License Application). Currently classified as an NDA (New Drug Application), such a change, if not managed well, could have severe repercussions on industry supply.

In response to the manufacturers’ request, and to help mitigate for potential technical compliance issues, BPOG established the ‘505 Team’. The team will develop a coordinated, timely industry response – across licence maintenance, post approval changes and manufacturing.

The objectives of the program are: to achieve a smooth transition before 2020, maintain the supply of quality products to patients and, through collaboration, minimize the effort for manufacturers and regulators during the transition.

The program includes:
• Interpreting the regulations: through company peer review, concluding in an understanding of regulatory requirements
• Exploring scenarios and potential solutions: developing generic scenarios where regulatory requirements may have impact, through an industry-aligned risk assessment process
• Refining solutions: making presentations at appropriate events, meetings and conferences, and seeking feedback from regulators on proposed solutions, leading to the publication of a position paper.

A recent meeting in London saw members agree on key scenarios and highlight priority risk areas which will be further developed and reviewed at the next meeting scheduled for September in New York.

Note: This collaboration considers ‘Regulatory CMC’ issues. Other industry group initiatives e.g. PhRMA, PDA, Bio, include wider related topics.

For further information, contact Jonathan Dakin

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