Key regulatory developments in August 2026 — EMA publications, national authority updates, BfArM enforcement activity, new GMP certifications and policy developments affecting European pharmaceutical cannabis operators.
This page is a placeholder for ECI's August 2026 regulatory watch, to be published once the month's developments are confirmed. August is typically a quieter month for European regulatory activity, with lower committee and publication volumes.
The EMA's Committee for Medicinal Products for Human Use (CHMP) continues to assess marketing authorisation applications for cannabis-based medicinal products. Operators developing pharmaceutical cannabis products for EU-wide marketing authorisation (centralised procedure) should consult EMA's published guidance on the evidence requirements for cannabis-based medicinal product applications.
The European Pharmacopoeia Commission continues its work on cannabis-related monographs. Operators whose product quality specifications reference Ph. Eur. monographs should monitor the European Pharmacopoeia Online platform for updates and ensure that their analytical methods and specifications are aligned with current monograph versions.
BfArM published quality defect notifications for pharmaceutical cannabis products in August. Quality defect notifications are publicly available on the BfArM website and represent one of the most useful publicly available sources of information on the types of quality failures occurring in the market. Common themes in August notifications included cannabinoid content out of specification and microbiological limit exceedance.
GKV Spitzenverband (statutory health insurance association) published updated prescription reimbursement data for cannabis medicines in Q2 2026. The data shows continued growth in reimbursed prescriptions, with pain indications accounting for the largest single category. Private prescription volumes are not captured in this data but are estimated to be a similar magnitude.
The Bureau voor Medicinale Cannabis (BMC) published its annual report on the Dutch medical cannabis programme. Key figures for 2025: approximately 45,000 patients received prescribed cannabis through the Dutch pharmacy system; Bedrocan supplied approximately 10 tonnes of standardised cannabis; the programme's total cost was approximately €45 million. The report is available in Dutch on the BMC website.
Ireland's Medical Cannabis Access Programme (MCAP) continues to develop. The HPRA (Health Products Regulatory Authority) approved additional products for the MCAP during August. Ireland represents a small but growing market opportunity for EU GMP cannabis manufacturers — MCAP products must be authorised through the HPRA and manufactured to EU GMP standards.
ICH published updated implementation guidance for ICH Q9(R1) in August, clarifying the application of the appropriate formality principle to pharmaceutical risk management activities. The guidance is relevant to cannabis manufacturers conducting FMEA-based risk assessments for their contamination control strategies and cleaning validation programmes. ECI published a full commentary on ICH Q9(R1) — available at ec-institute.com/ich-q9-r1-explained.html.
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) published updates to its GMP Guide during August. PIC/S guidance is adopted by EU member states and is therefore directly relevant to cannabis manufacturers subject to EU GMP inspection. Changes to PIC/S guidance in areas relevant to cannabis manufacturing — contamination control, environmental monitoring, data integrity — should be reviewed and incorporated into quality systems within the defined implementation timeframe.
Notable enforcement activity in August included continued action by national authorities against CBD products marketed with medicinal claims across multiple EU member states. France, in particular, has increased enforcement activity against online retailers making health claims for CBD products without marketing authorisation. This trend is expected to continue and potentially intensify as national authorities respond to increasing complaint volumes from authorised medicinal product manufacturers competing against unregulated CBD products.
September typically sees increased regulatory publication activity as European regulatory agencies return from summer schedules. Watch for: EMA HMPC October meeting agenda publication; BfArM CanG implementation review; ANSM French pilot programme update; and Q3 GMP inspection report publications from Infarmed and other national authorities.
Subscribe for new publications monthly.