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GMP

Regulatory timeline

A timeline of confirmed regulatory dates

Every entry below is a confirmed primary-source fact. If we can’t confirm a date, we leave it off the list rather than guess. Corrections to our own pages are recorded here too, with the date each was made.

  1. 2009-09-01

    Annex 7 operative

    EU GMP Annex 7 (manufacture of herbal medicinal products) in force. CONFIRMED against the European Commission text.

  2. 2011

    Annex 11 operative version

    Annex 11 covers computerised systems, and the 2011 text is the operative one. A proposed revision and a separate AI annex are drafts and are not binding.

  3. 2015-10-01

    Annex 15 operative

    Annex 15 covers qualification and validation. Equipment is qualified in context at a site, and it is not certified as an intrinsic property of a skid.

  4. 2022

    Annex 1 revision

    The revision covering sterile manufacture is the operative Annex 1. Its Grades A–D and a documented contamination control strategy (CCS) apply to sterile products, so don’t copy Grade C onto a non-sterile extract room.

  5. 2025-07-09

    GACP Rev. 1 adopted

    The revised GACP guideline, EMA/HMPC/246816/2005 Rev. 1, was adopted on 9 July 2025.

  6. 2025-08-12

    GACP Rev. 1 published

    The revision was published on 12 August 2025 and supersedes the 2006 guideline. It is the current EU reference for the agricultural stage.

  7. 2026-04-28

    US cannabis — partial Schedule III

    Only FDA-approved marijuana products and state-licensed medical marijuana moved to Schedule III. All other marijuana remains Schedule I, so there is no blanket “marijuana is Schedule III.” Re-check the primary record before you rely on it.

  8. 2026-09-23

    Corrections to our own pages

    We corrected these statements after checking them against the primary texts.

    • ICH Q7 puts change control in §13, not §11, and qualification in §12 rather than in the equipment chapter, §5.
    • The FDA’s guidance on responding to a Form 483 is a March 2026 draft, and it recommends a response within 15 business days.
    • The FDA describes cleanroom air by ISO class; Grades A–D belong to EU GMP Annex 1.
    • Under Annex 7, it’s the manufacturing authorisation holder’s use of a herbal material that decides how it’s classified.
    • EudraGMDP lists only certificates issued by EEA authorities.
    • Recovered-solvent controls apply to any reused solvent, not just ethanol.
    • The US Division and EU Zone schemes for flammable atmospheres serve the same purpose without being equivalent.

    We also corrected several glossary definitions, including CAPA, audit trail, ALCOA+ and the Qualified Person.