Agency IQ

NOVEMBER 20, 2023

readability of package leaflet, patient engagement). Summary of Product Characteristics and Package Leaflet), recommending that sponsors and regulators “explore the use of electronic media” to provide product information “in the future”. See also Article 11 of Directive 2001/83/EC.)

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Agency IQ

NOVEMBER 3, 2023

The Pharmaceutical Group of the European Union (PGEU) conducted a survey finding shortages worsened in 2022 compared to 2021, with most European countries reporting worsening. The Pharmaceutical Strategy document notes that Covid-19 just compounded medicines shortages that had already impacted patient health and the E.U. wide level.

Regulations 40

Regulations International Pharmaceuticals Production 40

Agency IQ

JULY 12, 2024

In October 2024, the European Commission published a communication putting forth a package of reforms to address medicines shortages. The Commission’s communication was accompanied by a Q&A document defining key terms and ideas, including how the effort was related to ongoing efforts to overhaul the pharmaceuticals legislation.

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Regulations Packaging Production FDA 40

Agency IQ

JANUARY 26, 2024

In 2001, the American Medical Association (AMA) conducted a survey of relevant stakeholders – including PhRMA, the U.S. Pharmacopeia (USP) and the FDA – to clarify whether the “actual ‘shelf life’ of many pharmaceutical products might be considerably longer than the expiration date that appears on the manufacturer’s container.”

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Science FDA Packaging Production 40

Agency IQ

AUGUST 4, 2023

pharmaceutical law ceased to apply to the U.K. s Medicines and Healthcare products Regulatory Agency (MHRA) has been releasing guidance for the pharmaceutical and medical device industry to aid product development and approval after the separation. Pharmaceutical Directive. s official exit from the E.U. as of January 1, 2021.

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Packaging Licensing Licensing Regulations 40

Agency IQ

JUNE 21, 2024

It applies to products with marketing authorizations according to Regulation (EC) No 726/2004 and Directive 2001/83/EC, but does not apply to the transfer of the marketing authorization from one holder to another. In April 2023, the Commission issued proposals to revise the current pharmaceutical Directive and Regulation.

Regulations 40

Regulations Marketing Production Vaccine 40

Agency IQ

APRIL 12, 2024

The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation This week, the European Parliament voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. Directive 2001/83/EC and Regulation (EC) No 726/2004.

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Pharmaceuticals Packaging Regulations Production 40