Pharma GMP News of the Week: 29-May-2022

Period: May 22, 2022 to May 28, 2022

The EC’s Medical Device Coordination Group (MDCG) issued a  Q & A to support industry to comply with unique device identification (UDI) requirements under the MDR and IVDR

Date of issue: May 20, 2022

The 45 pages report provides a comprehensive overview of its activities and achievements through the year 2021. 

Topics covered under heading quality and use of medicines are – The European Pharmacopoeia, Reference standards, Certification of suitability to the Ph. Eur. monographs, The European Network of Official Medicines Control Laboratories, Response to nitrosamine contamination, Anti-falsification activities, Pharmaceuticals and pharmaceutical care and European Paediatric Formulary. To read the entire report, refer to the following source link.

Source: https://ec.europa.eu/health/system/files/2022-05/mdcg_2022-7_en.pdf

The 2021 annual report of the European Directorate for the Quality of Medicines & HealthCare (EDQM) published on its website

Date of issue: May 23, 2022

The 45 pages report provides a comprehensive overview of its activities and achievements through the year 2021. 

Topics covered under heading quality and use of medicines are – The European Pharmacopoeia, Reference standards, Certification of suitability to the Ph. Eur. monographs, The European Network of Official Medicines Control Laboratories, Response to nitrosamine contamination, Anti-falsification activities, Pharmaceuticals and pharmaceutical care and European Paediatric Formulary. To read entire report, refer to the following source link.

Source: https://www.edqm.eu/documents/52006/602451/EDQM+Annual+report+2021.pdf/c12469ef-0b98-afab-eaa9-5170b7274f0b?t=1653313176032

The European Medicines Agency has published the final revised guideline to supports development of new antibiotics

Date of issue: May 24, 2022

To support a global approach with respect to new antimicrobial medicines development, EMA has published this final guideline.

This guideline provides information on the evaluation of medicines that can be used for the treatment of bacterial infections.

 The revised guideline consists of following:

  • Suggestions and clarity about clinical development programmes;
  • Guidance on clinical trials for UTI and Gonorrhoea;
  • Showing microbiological and clinical data in the summary of product characteristics.

Source: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-evaluation-medicinal-products-indicated-treatment-bacterial-infections-revision-3_en.pdf

US FDA has published final guidance on “Importation of Prescription Drugs Final Rule Questions and Answers; Small Entity Compliance Guide”

Date of issue: May 25, 2022

The objective of the guideline is to help understand the rule, “Importation of Prescription Drugs,” that was published on 1-Oct-2020 (85 FR 62094). 

 The purpose of the final rule was to get a good amount of reduction in the cost of covered products to the American consumer with no additional risk to the public’s health and safety.

Source: https://www.fda.gov/media/158659/download

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