What is the future of EU-GMP in medical cannabis?
The legal base is being rewritten, certificates carry less weight, and the duty to verify stays with the buyer: my reading before the PTMC panel in Lisbon.
The legal base of EU-GMP is being rewritten while the market that depends on it is still learning to read the current one. The reform of the EU pharmaceutical legislation will replace Directive 2001/83/EC, the text that today obliges manufacturers to verify their active substance suppliers through audits, and the compromise texts were confirmed in March 2026, with formal adoption expected in the course of the year. My reading, which I will defend on stage at PTMC in Lisbon on 10 September, is that three things define the next years: article numbers change while the architecture of responsibility does not, because the buyer remains the only party obliged to look at the supplier; certificates keep their value as evidence and lose the market’s habit of treating them as qualification; and regulators press exactly where the industry is weakest, the boundary between GACP and GMP and the substance behind the paperwork. None of this needs waiting for the new directive. It is already in the texts.
Will the new EU pharmaceutical legislation change GMP?
The structure changes, the burden does not move. Proposed in April 2023, the reform reached a political agreement in December 2025; the compromise texts were confirmed and published in March 2026, formal adoption is expected during 2026, and application follows a transition of roughly two years. The new directive replaces Directive 2001/83/EC, so the article every quality manager quotes on supplier audits, point (f) of Article 46, will carry a new number. What I have not found anywhere in this reform is a transfer of the burden: no authority becomes obliged to routinely inspect the active substance manufacturer, and the party required to verify that supplier, through audits conducted directly or under contract, remains the manufacturer who uses the material. Renumbering is not relief. If your supplier qualification stands on a paragraph number, it needs updating; if it stands on evidence, nothing changes.
Will GMP certificates still matter?
Certificates will matter for exactly what they are, a record that an authority inspected one site, for one scope, on one date, published in EudraGMDP. There is no “EU-GMP certificate” issued by the Union, and no rule that gives a GMP certificate a validity of three years: those are market habits, not regulatory facts. A certificate tells you where an inspector has already looked, which is useful risk information. It does not tell you how the site runs your material, this season, for your intended use. That is why I keep one working rule on both sides of the table: a certificate is a reason to audit a supplier less often. It is not a reason to stop auditing. The qualification lives in the buyer’s pharmaceutical quality system, where ICH Q10 places it: assessment before outsourcing, monitoring after. The future devalues the certificate-as-passport and revalues the certificate-as-evidence.
Are third-party audit reports a conflict of interest?
They can be, and the EMA has written down exactly when. The EMA GMP Q&A on Part II, updated in April 2025, lists among the conflicts to declare the contract auditors who “stand to make commercial gain from sale or supply of an audit report”, the model where one report is resold to multiple authorisation holders using the same supplier. That is a different animal from a second-party audit commissioned inside one client’s quality system, where the report belongs to the client and feeds their decision. The same Q&A sets the control downstream:
The QP has the ultimate responsibility to ensure that audit reports are properly evaluated when the audit is performed by a third party.
The evaluation is a written final assessment covering contractual arrangements, scope and duration, auditor competence, frequency and CAPAs. The audit report is an input the Qualified Person takes apart in writing, never the last word. A future with more audits only works with this discipline attached.
Where will regulators press next?
On the boundary, and on the substance behind the paperwork. The question I hear most, where GMP starts on a flower, has no one-line answer in the EU texts: the GACP guideline hands drying and cutting to the Annex 7 table, the table marks that row under three regimes at once, and Part II asks the manufacturer to designate and document the rationale for the starting point. Authorities have begun testing that seam: in 2026 the pharmaceutical supervisory authority of the German Land of Hesse, one Land authority rather than the federal BfArM, circulated a note reading controlled drying of cannabis flowers as a critical manufacturing step. Add the economics: prices in the main European markets have fallen while volumes grow, and the temptation to save on controls grows with the margin squeeze. Regulators read the same newspapers. The pressure will land on whoever cannot show a designated, documented, defended boundary and real evidence behind the batch.
What should importers and producers do now?
Treat qualification as a process you own, and let the evidence tell the story before an inspector asks. In practice, three things: run supplier qualification inside your quality system, assessment before and monitoring after, not a folder of collected certificates; ask every supplier for the boundary file, where GMP starts on their process, designated, documented and reasoned; and give audits the duration and scope the EU GMP Guide demands, so the report reflects what was done and seen. On 10 September I will test this reading at PTMC in Lisbon, in the roundtable “The Future of EU-GMP: Building the Next Generation of Cannabis Products & Operations”, alongside Luís Meirinhos Soares, consultant and EU-GMP auditor and former Infarmed inspector, Maria Villota of Flextem Pharma and pharmacist José Vera-Cruz, moderated by Ricardo Baca of Grasslands. My opening position is on this page. The future of EU-GMP in this sector is not a new certificate: it is verifiable evidence, owned by the buyer.
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