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news

News from the world

02

Feb

WHO is releasing an urgent call to action to countries to prevent, detect and respond to incidents of substandard and falsified medical products.

WHO calls on regulators and governments to: 

 

  • detect and remove from circulation in their respective markets any substandard medical products that have been identified in the WHO medical alerts referred to above as potential causes of deaths and disease;  
  • ensure that all medical products in their respective markets are approved for sale by competent authorities and obtainable from authorized/licensed suppliers;
  • assign appropriate resources to improve and increase risk-based inspections of manufacturing sites within their jurisdiction in accordance with international norms and standards;
  • increase market surveillance including risk-based targeted testing for medical products released in their respective markets including informal markets; and
  • enact and enforce, where relevant and as appropriate, laws and other relevant legal measures to help combat the manufacture, distribution and/or use of substandard and falsified medicines.

WHO calls on manufacturers of medicines to:

  • only purchase pharmaceutical grade excipients from qualified and bona fide suppliers;
  • conduct comprehensive testing upon receipt of supplies and before use in manufacture of finished products;
  • provide assurance of product quality including through certificates of analyses based on appropriate testing results; and
  • keep accurate, complete and proper records of purchase of materials, testing, manufacture, and distribution to facilitate traceability during investigations in case of incidents.

WHO urges all suppliers and distributors of medical products to:

  • always check for signs of falsification and physical condition of medicines and other health products they distribute and/or sell;
  • only distribute and/or sell medicines authorized by, and from sources approved by, competent authorities;
  • keep accurate, complete and proper records relating to the medicines and their distribution and/or sale; and
  • engage competent personnel to handle medicines and provide advice to the public on appropriate use of the medicines.

01

Feb

FDA Updates Policy Manual on Voluntary Withdrawal of Approved ANDAs

The FDA has updated its Manual of Policies and Procedures (MAPP) concerning receiving and processing...

01

Feb

EMA update on shortages of antibiotics in the EU

EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) met...

01

Feb

EMA pubblica la linea guida su classificazione dei medicinali veterinari ai fini della prescrizione

Il Comitato per i medicinali veterinari (CVMP) dell’EMA ha adottato la Guideline on the application...

31

Jan

FDA Publishes FY 22 GDUFA Science and Research Report

FDA’s Center for Drug Evaluation and Research  published its Fiscal Year (FY) 2022 Generic...

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