Real Generics’ Regulatory News Digest For Generics – 16 July 2015

EMA has issued product-specific bioequivalence guidance for:

  • Sirolimus 0.5 mg, 1 mg and 2 mg coated tablets and 1mg/ml oral solution
  • Sorafenib 200mg film-coated tablets
  • Sunitinib 12.5mg, 25mg, 37.5mg and 50mg hard capsules
  • Tadalafil 2.5mg, 5mg, 10mg and 20mg film-coated tablets
  • Telithromycin 400 mg film-coated tablets
  • Voriconazole 50 mg and 200 mg tablets and 40 mg/ml oral suspension
  • Capecitabine 150 mg and 500 mg film-coated tablets

The guidance comes into effect on 1 November 2015.

EMA Day 80 Assessment Report Template – Preclinical and Clinical – Generics

EMA has issued a revised guidance document on the content of the Day 80 critical assessment report for generic medicinal products. The guideline is a useful tool for generic companies because it gives insight into EMA’s expectations for a generic submission.

A full set of EMA assessment templates can be found here.


Real Generics Ltd is a member of the Real Regulatory Group. The partner company, Real Regulatory Ltd, is a consultancy firm specialising in European Regulatory Affairs, Quality Management Systems and Supply Chain Operations Compliance for the pharmaceutical, medical device and aligned industries.

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