Regulatory news, with the “so what” attached
Guidance changes, inspection trends and industry developments that affect Dutch manufacturers. Every entry answers the same two questions: what changed, and what does a site with a lean quality team have to do about it.
- EMA and EudraLex
- CBG-MEB and IGJ
- EDQM
- PIC/S
- FDA warning letters and 483 summaries
- MHRA inspectorate blog
- Notified body guidance
Each one follows the same format
What changed, who it applies to, and what a site with a lean quality team has to do about it. Subscribe and it reaches you without you having to check back.
- Guidance
An Annex or chapter revision is published
What changed in the text, which sites it applies to, the transition period, and the two or three documents at your site that will need to change. Ends with a plain statement of whether this is urgent for a mid-size manufacturer or not.
Source: EudraLex Volume 4 · linked to the primary document
- Inspection
A quarterly read of published inspection findings
Recurring deficiency themes from published EU and FDA outcomes, grouped by quality-system area, with a note on which of them a self-inspection would realistically have caught first.
Source: Published inspection outcomes and warning letters
- Netherlands
National developments: IGJ, CBG-MEB and Dutch industry
Inspectorate priorities, Dutch-language guidance, licensing and supply developments relevant to sites operating here rather than to the EU generally.
Source: IGJ and CBG-MEB publications
- Devices
MDR and notified body capacity
Certification timelines, guidance from the MDCG, and what a manufacturer should be preparing now rather than when the renewal window opens.
Source: MDCG guidance and notified body announcements
- Firm news
From the practice
New capabilities, publications, speaking appearances and the annual readiness index. Kept short and kept honest: this is the smallest section for a reason.
Source: GMP Consultant
Monthly regulatory note
A short monthly note, sent only when there is something worth sending. Roughly ten per year. No sequences, no drip campaign, unsubscribe in one click.
Used only to send this note. Not shared, not sold, not used for anything else.
Something in the guidance you are unsure about?
If a revision has landed and you are not certain what it means for your site, that is a good fifteen-minute conversation.