In view of the recent need for the fast development of medicinal products for COVID-19, the World Health Organization (WHO) published a new guideline on Good Manufacturing Practice (GMP) for development batches. According to the WHO, there are currently no regulatory guidelines available which address this matter.
In view of recent experiences from inspections carried out for COVID-19 therapeutics, the World Health Organization (WHO) published a new working document entitled "GOOD MANUFACTURING PRACTICES FOR INVESTIGATIONAL PRODUCTS".
The requirement for a "written GACP declaration" is contained in the current draft of the EMA HMPC Guidance Document "Quality of Herbal Medicinal Products". However, some questions remain: Who creates the declaration and what does it look like?
The U.S. FDA revised the text of their "intended use regulation" to provide additional examples and explanation. In particular clarity is provided by describing examples of types of evidence the agency would consider relevant to determining the intended use of a product.
Herbal Medicinal Products: HMPC's Statement on Pyrrolizidine Alkaloids
The Herbal Medicinal Products Committee (HMPC) of the EMA has published the draft of the updated public statement of the HMPC on pyrrolizidine alkaloids (PAs). The document contains, among other things, the limits for the maximum daily intake of PAs.
Corona: What measures have Governments taken in the Life Sciences Sector?
Governments have been implementing different emergency measures in the fight against the current pandemic. Now an overview of the various measures in the EMEA region has been published.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has just published a Guidance for Wholesaling and Importing Activities after the end of the Transition Period.
How are FDA Inspections and Applications impacted by COVID-19 Restrictions?
The FDA has published a Q&A document with respect to inspections, pending drug applications, and changes in manufacturing facilities for approved pharmaceutical products.
The FDA issued a new guideline entitled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research”. The draft guidance also introduces key FDA regulatory concepts to stakeholders who may be less familiar with the FDA and the FDA’s authorities than other drug developers.
EMA Clarifies Investigators Responsibilities Regarding the eCRF
The EMA has updated the Q&As on their Good Clinical Practice (GCP) page. In particular, a new Q&A Nr. 13 clarifies the responsibilities of sponsors and investigators regarding data entered into the eCRF and PI oversight.