By Mindy Gagnon - PCI Senior Director, Quality
The revision of EU GMP Annex 1, "Manufacture
of Sterile Medicinal Products," has significantly
reshaped regulatory expectations for sterile
pharmaceutical manufacturing. The updated
guidance, which came into effect in August
2023, introduces new requirements and
reinforces established principles around
contamination control, quality risk management
(QRM), and the application of advanced aseptic
processing technologies. For sterile fill-finish
operations, Annex 1 represents a significant shift
toward risk-based, lifecycle driven compliance
with an emphasis on process robustness and
contamination prevention.
Read in the digital edition
- PHARMAnetwork magazine n° 66, page 46
By Christian Lindenthal & Annelie Säurig - Bird and Bird
As part of its pharmaceutical law reform,
the EU legislator has proposed a modernised
framework for combination products – products
that combine multiple active substances
within a single product or integrate medicinal
products with devices, technologies, or other
components. The goal: to foster innovation,
reduce regulatory ambiguity, and ensure faster,
safer access to cutting-edge therapies.
Read in the digital edition
- PHARMAnetwork magazine n° 66, page 52
By Clarissa Junge-Gierse - Bird and Bird
On 4 June 2025, the Council published its stance
on the “pharma package”, introducing notable
changes that will influence how paediatric
medicines are developed across the EU. In this
article and following our July 2023 analysis of
the European Commission’s proposed reforms
to the regulation of paediatric medicinal
products (“PMPs”) and our October 2024
review of the EU Parliament's adjustments to
these proposals, we examine the Council's key
amendments and their potential impact on the
pharmaceutical industry
Read in the digital edition
- PHARMAnetwork magazine n° 66, page 54
By Pieter Erasmus & Doyin Oyekan - Bird and Bird
On 12 December 2024, the Medicines for Human Use
(Clinical Trials) (Amendment) Regulations 2024 were
laid before Parliament. These were subsequently signed into
law during April 2025 and will come into force on 28 April
2026 following a 12-month transition period.
These amendments propose important changes to the
processes involved in clinical trials in the UK. The focus of
these amendments is to bring a greater level of harmonisation with EU regulation and international legislative standards, streamline the process for sponsors and increase flexibility while ensuring safety and transparency for patients.
Read in the digital edition
- PHARMAnetwork magazine n° 65, page 62
By Bénédicte Mourisse, Marc Martens & Sarah Faircliffe - Bird and Bird
The ‘pharmaceutical package’ includes: A new directive: This will replace the current Directive
2001/83/EC, offering an updated set of rules.
A new regulation: This replaces and amalgamates Regulations 726/2004 (covering the European Medicines Agency
(EMA) and the centralised procedure), 1901/2006 (paediatric medicines), and 141/2000/EC (orphan medicinal
products) and also introduces additional new rules, for
example for transferrable data exclusivity vouchers for
priority antimicrobials and for the coordinated management of medicines shortages and critical shortages and
the supply of critical medicines.
Read in the digital edition
- PHARMAnetwork magazine n° 65, page 64
