In response to the COVID-19 outbreak, FDA has decided to postpone most foreign inspections until the end of April.
The EMA and its partners are closely monitoring the potential impact of the outbreak of the novel coronavirus disease (COVID-19) on pharmaceutical supply chains into the EU.
The new chapter 5.17.2 in the European Pharmacopoeia "Recommendations on testing of particulate contamination: visible particles" was already published for comment in autumn 2018 (Pharmeuropa 30.4). The comments and feedback received have been considered by the Expert Group 12 of the EDQM, and the chapter is coming into force.
A US-American medical manufacturer has received a Warning Letter from the FDA due to foreign particles in a solution for oral application and especially regarding the handling of this incident. Besides, further deficiencies were observed during the inspection, such as errors in the evaluation of HPLC data and data integrity in the laboratory in general.
Following the adoption of the ICH Q12 Guideline in November 2019 the EMA recently published the ICH Q12 Step 5 Guideline and its annexes - together with an Explanatory Note.
UK will implement faster access to medicinal cannabis as import restrictions are changed. Thus, patients will be able to get their treatment in days rather than months.
A Chinese company was placed on import alert by FDA because investigators observed significant deviations from cGMP. In some cases, the company told the untruth.
The revised draft of Annex 1 (Manufacture of Sterile Products) was published. There are also some things to consider for QPs.
Some major European industry associations call for a UK-EU Mutual Recognition Agreement to avoid drug shortages and other problems.