Drugs

Stakeholders Suggest Q12 Changes

Pharmaceutical Research and Manufacturers of America (PhRMA) says the International Council for Harmonization (ICH) document Q12, Technical and Regulatory Considerations for Pharmaceutical Product Lifestyle Management, could benefit from additional examples and clarity around the application of the specific tools and enablers introduced by the guidance. In just-released 12/15/18 comments, PhRMA says it believes the draft guidance is based on sound philosophical concepts and offers potentially useful regulatory tools and enablers.

“If well-executed and implemented,” the letter says, “the concepts and tools articulated in the guidance hold out the promise of reduced regulatory uncertainty and more efficient post-approval chemistry, manufacturing, and controls changes. PhRMA is concerned, however, that this draft guidance presents an overly complex framework that will be difficult to carry out without significant clarifications and resource-intensive actions upon implementation.”

The trade association also expresses a concern that the draft does not provide sufficient flexibility for sponsors and also says the scope of the draft is not completely clear.

The U.S. Pharmacopeia comments that the ICH and FDA efforts to develop a harmonized approach on technical and regulatory considerations for product lifecycle management will benefit patients, industry, and regulatory authorities. “The concepts outlined in Q12 align with a critical vision for harmonizing pharmaceutical quality approaches that integrates risk management thinking and emphasizes science,” it says.

Merck supplied specific line-by-line comments and suggested that once Q12 is finalized, FDA consider revising or withdrawing several related and overlapping guidances.

Finally, the Parenteral Drug Association says that if implemented as intended by regulators and industry, Q12 could help facilitate enhanced continual improvement and innovation and reduce the number of drug shortages that are aggravated by the global regulatory complexity. It also discussesArticles three areas it says could improve the guidance’s usefulness.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome