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Bridging the healthcare digital divide: a gradual approach to adopting ePI

European Pharmaceutical Review

These standardised documents provide meticulously curated and scientifically approved information. Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC.” Article 63 EMA (29 January 2020).

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Bob Tribe, ISPE Asia-Pacific Regulatory Advisor, Retires

ISPE

While at TGA Bob also served as Deputy Chairman of PIC/S during 1998-1999, followed by a tenure as Chairman of PIC/S from 2000-2001. 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.

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

European Pharmaceutical Review

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

FDA 103
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Sweeping changes in leaked EU pharma law draft reignite profit vs access conflict

Pharmaceutical Technology

But the EU draft document says that the changes will make medicines more affordable, improve unequal access to medicines across the EU, and fulfil unmet patient needs.

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EU pharmaceutical legislation revisions: what are the implications for biopharma?

European Pharmaceutical Review

In October 2023, the European Parliament (EP) proposed revisions to the European Commission proposals with diverging views on various topics set out through two documents. Figure 2: European Commission proposed changes to regulatory data protection periods for non-orphan and orphan drugs (Source: L.E.K) What are the latest amendments?

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Psychedelics, Pregnancy, and Breastfeeding

The Spirit Pharmacist

There have been a couple of small case series document LSD use in pregnancy and normal birth outcomes, although these are not high quality or conclusive by any means [23]. Neurotoxicol Teratol, 2001. Nevertheless, several case reports of ophthalmic or limb abnormalities born to mothers who used LSD exist in medical literature [19-22].

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Preparing for stricter standards on substances of human origin

European Pharmaceutical Review

SoHO entities must implement a traceability system to unmistakably link each SoHO donor to their SoHO donation and to all documents, samples, SoHO preparations and SoHO entities that are associated with that SoHO from the point of collection to human application and outcome monitoring.