As previously reported, the FDA is working on a system that will help to identify and trace dangerous drugs that are counterfeit, stolen or tainted throughout the whole supply chain. Together with drug manufacturers, wholesaler distributors, repackers and many dispensers the FDA is working on the development of standards for this new system.
The EMA has published the “Draft guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission”.
With the beginning of this month, the FDA has published the following two updated lists of guidance documents:
This month, the WHO has published a proposal for the revision of the supplementary guidelines on GMP: Validation, namely Appendix 7 – non-sterile process validation. A presentation to the WHO Expert Committee is planned for October 2014.
The European Commission has published the final version of Chapter 6 Quality Control of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use on April 3, 2014.
The revised document will enter into force on 1 October 2014 and then supersede the previous version of 2005.
On 1 April 2014, the European Commission has published a “Question and Answer” document (version 1.0, March 2014) responding to frequently asked questions in relation to the guidelines on Good Distribution Practice of medicinal products for human use.
According to the China Food and Drug Administration CFDA, the Chinese government on Monday unveiled a revised regulation on the supervision of medical equipment to enhance its safety and effectiveness and safeguard public health.
The FDA plans to reduce its number of routine GMP inspections in the U.S. by 40 % and thus to scale up its inspections overseas. This new strategy shall improve the quality of drugs imported into the U.S. and will bring the FDA closer to achieving its longtime goal of bringing parity to domestic and foreign inspections.
The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have set up a new 'cluster' on pharmacovigilance (medicine safety) topics.
The FDA initiates the Secure Supply Chain Pilot Program to enhance the security of imported drugs. So far thirteen prequalified companies have been accepted for participation and will receive expedited entry for the importation of up to five selected drug products into the United States.
The CFDA has announced the adoption of the draft amendment to the Regulations for the Supervision and Administration of Medical Devices at the executive meeting of the State Council on February 12, 2014. The regulations will be promulgated and implemented soon.
As announced by the Swiss Regulatory Authority Swissmedic, a Memorandum of Understanding in the area of therapeutic products was signed with the Korean Ministry for Food and Drug Safety (MFDS). This was part of a state visit of the President of the Republic of Korea.
The FDA has published its yearly guidance agenda including the new and revised draft guidances CDER is planning to publish during the calendar year 2014.