Remove 2005 Remove Documentation Remove FDA
article thumbnail

Annex 1 Implementation Strategies

ISPE

First published in 1989, there have been a total of 5 adaptations in 1996, 2003, 2005, 2007 and 2009, but no complete revision. Annex 1 of the EC GMP Guide " Manufacture of Sterile Medicinal Products " has a long history. In 2012, there was a proposal for a complete revision which resulted in a concept paper in 2015.

article thumbnail

Bob Tribe, ISPE Asia-Pacific Regulatory Advisor, Retires

ISPE

Bob also initiated an agreement under which ISPE’s Guidance Documents are made available to PIC/S and WHO inspectors, which is still in place today. Most recently he assisted the regulatory authorities of Saudi Arabia, Russia, China, Jordan, and Philippines in the process to attain PIC/S membership.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

FDA 103
article thumbnail

Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing

European Pharmaceutical Review

To give examples, such a work package focuses on the identification of regulations (ICH Q2 R2, 3 Q8-Q14, 4-10 FDA PAT guidance, 11 EMA Annex 15 12 ), some of which may be mainly guidance documents with recommendations and flexibility when it comes to PAT.

article thumbnail

The Good, Bad, and Ugly side of 510(k)s—HP&M’s Early Experience with the eSTAR Template for 510(k)s

The FDA Law Blog

Lenz, Principal Medical Device Regulation Expert — Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s. Several sections of the eSTAR templates have questions that walk through related guidance documents. By Adrienne R. Know Your Guidances.

article thumbnail

The future of medical cannabis development in Europe

European Pharmaceutical Review

It is estimated that only one in 10 drugs that enter Phase I trials are subsequently licensed by the US Food and Drug Administration (FDA). 5 When these medicines are prescribed to patients, we can use feedback from the real-world data that documents clinical outcomes, efficacy measures, patient-reported outcomes, and adverse events.

article thumbnail

CMC Requirements for New Drug Registration in Latin America

ISPE

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.