Controlled Drugs Manufacturing in Europe: Regulation, Nasal Delivery and CDMO Expertise

The growing role of nasal delivery for controlled drugs

Controlled drugs such as morphine, fentanyl and cannabis-based medicinal products are clinically essential across Europe — yet their manufacture is subject to some of the most stringent regulatory controls in the pharmaceutical industry.

In this in-depth article, Curida examines how demographic change, rising cancer incidence and evolving clinical practice are driving demand for controlled substances, while increased regulatory scrutiny is reshaping how and where these products can be manufactured. Particular focus is given to the growing acceptance of nasal administration as a safe, rapid and patient-friendly delivery route for high-potency analgesics.

Written by Muhammad Mohsin Asim, Senior Project Manager at Curida, the article explores why controlled drug manufacturing requires specialist facilities, robust governance and experienced teams — and why partnering with a licensed, European CDMO is becoming increasingly critical.

In the article, you’ll learn about:

- How controlled drugs are regulated across Europe
- Why nasal sprays are gaining momentum for controlled substances
- The facilities, security and QA systems required for compliance
- Common outsourcing challenges for pharma and biotech companies
- What to look for when choosing a specialist controlled drugs CDMO