Bengaluru : Indian pharma industry sees that the International Council for Harmonisation (ICH) guidance for industry on Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management provides a framework to expedite the management of post approvals in a well-organized way.
Specifically the Q12 includes regulatory tools to increase transparency between industry and regulatory authorities, supporting innovation and continual improvement. The guidance applies to drug substances and drug products that are new drug applications (NDAs), biologics license applications (BLAs), abbreviated new drug applications (ANDAs).
From an India standpoint, the pharma industry here is climbing up the value chain and bagging approvals from US FDA of NDAs and ANDAs with sustained investment on R&D. Going by the opportunity from the US, the industry here is looking to introduce new products after loss of marketing exclusivity. Currently, the industry has 336 ANDA approvals which include Sun Pharma, Cadila Healthcare & Zydus Pharma, Aurobindo Pharma, Lupin, Alembic Pharma, Alkem Laboratories, Glenmark Pharma, Dr Reddy’s Laboratories, Micro Labs, Gland Pharma, Torrent Pharma, Cipla, Ajanta Pharrma, to name a few, said industry observers.
According to Prema Desai, pharma consultant, the guidance facilitates the management of post approval chemistry, manufacturing, and controls (CMC) changes in a more predictable and efficient manner.
In fact ICH Q12 includes regulatory tools and enablers with associated guiding principles that should enhance industry’s ability to manage post approval changes and increase transparency between industry and regulatory authorities, supporting innovation and continual improvement, she added.
Coming back to the regulation, the guidance stated that in the US regulatory system, prior approval means changes being effected and documented within the pharmaceutical quality system (PQS) and do not need to be reported, but they may be verified during a surveillance or inspections.
Established Conditions (ECs) are legally binding information considered necessary to assure product quality. As a consequence, any change to ECs necessitates a submission to the regulatory authority. In fact this is on similar lines that of the US FDA regulations.
The risk-based paradigm set forth in the regulations and the recommendations in these associated norms documents can help, FDA’s scale-up and post approval changes (SUPAC) guidance for industry.
ECs based on the risk-based paradigm set forth in the regulations and the recommendations contained in guidance is voluntary. An increased understanding of the risk to product quality posed by a change to an EC may support a proposal for reduced reporting categories.
To ensure clarity regarding ECs when submitting an original NDA, BLA, or ANDA, applicants should: Include one of the following statements in the cover letter: Specific ECs are proposed. Specific ECs are not proposed; post approval changes will follow the regulations and the recommendations in guidance.
