Manufacturers and distributors of counterfeit medicines are becoming more sophisticated in terms of their ability to enter the legitimate pharmaceutical supply chain. In 2011 the European Council amended Directive 2001/83/EC to define the rules for manufacturing, importing, placing on the market, the wholesale distribution of medicinal products in the Union, as well as rules relating to active substances, by issuing the European…
FDA’s Draft Guidance of “Least Burdensome Provisions” for Medical Devices
In 1997, Congress passed the Food and Drug Administration Modernization Act of 1997 (FDAMA)1 in an effort “to ensure the timely availability of safe and effective new products that will benefit the public and to ensure that our Nation continues to lead the world in new product innovation and development.” Central to that legislation was the addition of section 513(i)(1)(D) and 513(a)(3) (D)(ii)…
FDA Updates Guidance on Electronic Records, Signatures
After issuing its controversial Guidance for Industry — Part 11, Electronic Records; Electronic Signatures — Scope and Application1 20 years ago, the FDA struggled with consistent enforcement of the guidance. At the time, industry countered with feedback that the new guidance presented an overhead model that was untenable from a business perspective. We have gained little insight into the FDA’s thinking since their…
Electronic Transfer of Regulatory Information
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that is used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. DMFs typically contain critical details required in support of the Chemistry, Manufacturing, and Controls (CMC) elements within a regulatory…
Understanding Annex 16 Changes for Qualified Persons and Batch Release
In the U.S. and Europe, the approach to ensuring drug quality has many more similarities than differences. But one key difference has always been the additional responsibilities placed upon the role of a Qualified Person or QP in ensuring the quality of a drug product. The European Union (EU) recently put in place new legislation…