The Medicines and Healthcare products Regulatory Agency (MHRA) published its annual compilation of marketing authorisations granted during 2025 on 13 April 2026. The publication, available on gov.uk, provides the definitive register of new medicines — including novel active substances, generic equivalents, and biosimilars — that received UK marketing authorisation during the calendar year.

Why marketing authorisations matter for pharmacy

A marketing authorisation (MA) is the regulatory approval that permits a medicine to be manufactured, marketed, and dispensed in the UK. For community pharmacists, each new MA has practical implications:

New dispensing requirements. Novel medicines may require specific storage conditions, patient monitoring, or dispensing protocols that differ from existing treatments in the same therapeutic area. Pharmacists encountering a newly authorised medicine for the first time should review the Summary of Product Characteristics (SmPC) before dispensing.

Patient counselling needs. Patients switched from an established medicine to a newly authorised generic or biosimilar may have questions about efficacy, side effects, and whether the new product is "the same." Pharmacists are often the first healthcare professional patients consult after a prescription change.

Formulary changes. NHS England formulary decisions typically follow 3–12 months after an MA is granted. Medicines authorised in 2025 may begin appearing on prescriptions throughout 2026 and into 2027, particularly where NICE technology appraisals recommend adoption.

The pipeline in context

Each year, the MHRA grants authorisations for a mix of entirely new active substances, new indications for existing medicines, and generic or biosimilar versions of medicines whose patents have expired. The practical impact varies:

• Novel active substances require the most preparation. Pharmacists may need to familiarise themselves with a new mechanism of action, drug interactions, and patient monitoring requirements.
• Generics are more straightforward but can generate patient anxiety. The most common pharmacy counter query — "Is this the same as my usual tablets?" — arises when a familiar brand name changes.
• Biosimilars sit between the two. The growing number of biosimilar marketing authorisations reflects both patent expiries on major biologics and NHS England's stated ambition to reduce spending through biosimilar switching.

Practical steps for pharmacy teams

Pharmacists and pharmacy technicians preparing for new medicines in the dispensing pipeline should consider:

1. Review the MHRA publication on gov.uk to identify authorisations relevant to their patient population. Community pharmacies with high volumes of respiratory, cardiovascular, or diabetes prescriptions may want to focus on those therapeutic areas first.
2. Check the NICE website for any associated technology appraisals or guidelines that will determine when and how new medicines enter NHS prescribing.
3. Update patient-facing materials where a widely prescribed medicine is due to be replaced by a generic or biosimilar equivalent.
4. Flag storage requirements for any new medicine that requires cold-chain handling or controlled-drug procedures.

PharmSee's job listings at /app/jobs show that specialist pharmacy roles — including those in clinical trials, medicines information, and formulary management — often list experience with new medicine introductions as a desirable criterion. For salary data across pharmacy roles, see PharmSee Salary Guides.

Caveats

This article references the MHRA's published compilation of marketing authorisations for 2025. PharmSee has not independently audited the full list. Marketing authorisation does not guarantee that a medicine will be prescribed in community pharmacy settings — many authorised medicines are hospital-only or specialist-use. The timeline from authorisation to routine NHS prescribing varies significantly by therapeutic area and NICE assessment schedule.