Regulatory Oversight

Aging populations and increased access to healthcare translates into opportunities for biopharmaceutical companies.

The EU’s key objectives include improving medicines access, tackling drug shortages, and increasing administrative efficiency in its regulatory framework.

FDA’s Center for Drug Evaluation and Research publishes a list of upcoming new and revised guidance documents for 2016.

FDA issued a warning letter to Chan Yat Hing Medicine Factory for CGMP violations.

FDA discusses a new program that allows pharmaceutical companies to submit proposals for new manufacturing technology.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to streamline the document management process during market expansion.

The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.

The agency has published draft guidance on safety assessment for investigational new drug application safety reporting.

FDA warns the industry of possible contamination in the API baclofen from Taizhou Xinyou Pharmaceutical & Chemical Co., Limited.

EMA Executive Director Guido Rasi outlines his plan for the agency, including a focus on R&D.

Changes in China’s Food and Drug Administration (cFDA) drug development and commercialization policies make it easier for multinationals and CMOs to manufacture in China for in-country use, reports CMO and consultant PaizaBio.

While stakeholders generally welcome improvements to quality initiatives, they are concerned with how the new requirements will be implemented for more complicated supply-chain models.

The agency publishes draft guidance on best practices for communication between FDA and IND sponsors during drug development.

Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to write standard operating procedures that hold up to audits.

The results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.

The agency promotes safer use of drugs and prevention of medication errors through a new webpage and practice guide.

Cambridge Consultants engaged in a workshop-style dialogue with a cross section of senior personnel from both Indian and multinational pharma companies to debate whether emerging markets are an opportunity to drive sustainable growth. Conclusions from the workshop are presented in this article.

Pharmaceutical manufacturing facilities can help prevent contamination and cross contamination by using color coding.

Operations at Catalent’s Beinheim, France, softgel facility were suspended following suspected deliberate action to misplace capsules.

The agency issues guidance on the labeling of over-the-counter products that contain acetaminophen.

The new executive director of the European Medicines Agency begins appointment.

The European agency presents guidelines for conducting post-authorization efficacy studies.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to ensure archive records can be retrieved.

Virtual pilot programs examine scenarios that may occur while implementing serialization requirements for the US Drug Supply Chain Security Act.

The scheme aims to ensure that EMA and licensing authorities of EU member states will use the same IT system, based on a single data standard.

The agency issued a draft guidance document on the requirements for submission of applications for liposome drug products.

USP responds to FDA's draft guidance on the naming of biological products.

The agency provides terms and recommendations for packaging and labeling of injectable medical products.

The excipient supplier's cGMP practices have been certified as meeting EXCiPACT standards