The long awaited and highly discussed ICH Q12 draft Guideline is now available online on the ICH website. Read more about ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.
Following the notified draft regulation published in 2016 the European Commission (EC) recently published a revised draft regulation on BPA. Read more about Bisphenol A in varnishes and coatings and plastics intended to come into contact with food.
With the resignation of Richard M Bonner as Chairman of the Advisory Board of both the ECA Foundation and the European QP Association (EQPA) the organsation has announced changes in the Advisory Boards of the ECA Foundation and the EQPA.
For several years, combination products have been regulated by 21 CFR 4 in the USA. In September 2017, the FDA issued a Warning Letter to a manufacturer of combination products. What did the FDA criticise?
In the first half of Fiscal Year 2017 review you could read about the Warning Letters issued to manufacturers of medical devices during 1 October 2016 through 31 March, 2017. Now, the numbers of Medical Device Warning Letters for the entire fiscal year 2017 (1 October 2016 - 30 September 2017) are available.
The WHO has published a finalised 76-page regulatory framework for medical devices including in vitro diagnostic medical devices (IVDs) divided into 5 chapters. What is the purpose of the document entitled "WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices"?
The new FDA guideline titled "Classification of Products as Drugs and Devices and Devices and Additional Product Classification Issues: Guidance for Industry" describes how the FDA classifies products as drugs, medical devices or other.
The USP General Chapters Packaging and Distribution Expert Committee recently posted the intent to revise General Chapter <381>. The Chapter currently includes a reference to <231> Heavy Metals, which will be omitted on January 1, 2018. Read more about the revision of Chapter <381> Elastomeric Closure for Injections.
The British Standards Institution (bsi), Group Japan, has developed a so called PAS (Publicly Available Specification) to specify requirements for temperature-controlled delivery services for chilled and frozen goods.
GDP Guidelines are certainly a hot topic in the EU and in WHO states. In the US, things are still developing but are getting more and more important, as the excerpts from recent Warning Letters addressing GDP isssues show.