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2022 spells change for EU pharmaceutical legislation

European Pharmaceutical Review

It is too early to say because we have not seen the whole package of measures yet. THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION; 2004. One of the key priorities of the EU’s strategy is to encourage innovation to solve unmet medical needs. THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION; 2006.

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FDA Issues Two Guidance Documents on Food Allergen Labeling Requirements

The FDA Law Blog

All packaged foods served or sold on transportation carriers (e.g., 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., labeling of major food allergens in bulk foods, dietary supplements, protein-free ingredients, and foods produced through genetic engineering); and.

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Five potential EU regulatory changes impacting the life sciences industry in 2023

European Pharmaceutical Review

Launch of the EU pharmaceutical package The European Commission plans to commence initiatives relating to the European Pharmaceutical Strategy (strategy) with the publication of the revised EU pharmaceutical package scheduled during the first quarter of 2023.

Packaging 117
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CMC Requirements for New Drug Registration in Latin America

ISPE

In addition to the COR, some Latin American markets require approval in the COO, which is defined as the country where the drug is manufactured, packaged, or exported from. Sometimes, COAs for the drug substance, the excipients used in the formulation, and the primary and nonfunctional secondary packaging material are requested.

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Pharmacy practice in emergency care: patient safeguarding

Hospital Pharmacy Europe

ED pharmacy services were surveyed for the first time in 2004. In the UK, safeguarding training for healthcare professionals comprises six levels, which increase in complexity, with separate learning packages for those who care for children or adults. So, UK ED pharmacy practice was born.

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Environmental Sustainability in Biopharmaceutical Facility Design

ISPE

4 The biopharmaceutical industry is taking steps to increase its environmental sustainability, 5 which begins with identifying and testing alternatives to existing procurement, materials, logistics, equipment, services, manufacturing processes, packaging, and facility design 6 (see Table 1). March 2004. 7 An integrative (vs.

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Air Speed Qualification: At Working Position or Working Level?

ISPE

October 2004. But it is likely that interpretations in practice refer to footnote 5 from FDA Aseptic Guidance 2004: 7 “A velocity of 0.45 x, a free and open-source computational fluid dynamics (CFD) software package. Pharmaceutical Engineering 37, no. 2 (2017): 44–46. 7 US Food and Drug Administration.