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PharmaVibe

Latest Release

Latest Release

 
Episode19: EU issues GMP Annex 1 final revision for sterile drug products
EPISODE 19 | 12 MIN | 31 August. 2022
#Drug Review   #R&D   #Business   #Policy
EU issues GMP Annex 1 final revision for sterile drug products

In the last week's Chinese pharma market, the 11th indication of BeiGene’s PD-1 Tislelizumab was declared for marketing for the treatment of esophageal squamous cell carcinoma.

While in the global pharma market, Johnson & Johnson’s Teclistamab was approved by the EC, making it the first BCMA/CD3 bispecific antibody approved for marketing worldwide. In addition, the EU officially released the eagerly anticipated final revision of its GMP Annex 1 for sterile drug products. 
Play (https://www.pharmasources.com/pharmavibe/detail/19.html/?utm_source=EDM&utm_medium=online&am p;utm_campaign=enedmpodcast0831)

 

CPHI China E-learn Series Webinar: China’s Quality and Therapeutic Equivalence Evaluation of Generic Drugs (https://www.pharmasources.com/zt/cphichinawebinar/equivalence-evaluation-of-generic-drugs?utm_source=EDM&utm_medium=online&am p;utm_campaign=enedmpodcast0831)
SEPTEMBER

22

4:00 pm CET | 10:00 am EST
CPHI China E-learn Series Webinar
China’s Quality and Therapeutic Equivalence Evaluation of Generic Drugs
 

Topic HighlightsRegulatory Requirements of Quality and Therapeutic Equivalence Evaluations of Generic DrugsHow Equivalence Evaluation Impacts Pharma MarketApplications for Equivalence Evaluation
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