Pharmaceutical quality of homeopathic medicinal products

A new study confirms that homeopathic medicinal products in the European Union are of a defined high quality, safe for patients and well-regulated.

A new study confirms that homeopathic medicinal products in Europe are of a defined high quality, safe for patients and well-regulated.

The study has been published in English in the publication pharmind, the journal for executives who consider Good Practice (GxP) rules from a pharmaceutical-scientific point of view.

The study describes how the safety of all medicines, including homeopathic medicinal products (HMPs), largely depends on their pharmaceutical quality. The requirements and methods for quality control of finished HMPs are as complex as for chemical medicinal products. While a marketing authorisation guarantees the evaluation of quality, safety and efficacy by the competent national authority before placing on the market, a manufacturing authorisation ensures that HMPs are manufactured by approved and officially audited manufacturers in accordance with the legal framework and principles and guidelines of Good Manufacturing Practices (GMP) throughout the entire marketing phase.

It outlines the important current legal and regulatory requirements for HMPs in the European Union (EU) and Germany. It focuses on the GMP-related responsibilities that apply to all market authorisation holders, including manufacturers of HMPs. As with all other medicinal products, this begins with the selection and cultivation of the raw materials and extends through production to quality tests and the market approval. The national competent authorities control the work of pharmaceutical companies and their suppliers and routinely audit the manufacturers. They take samples themselves and check the results of the company’s own controls. Only if safety and quality is guaranteed according to the EU-GMP guidelines of a (homeopathic) medicinal product is it distributed to the patients in the EU.

In recent years there have been several reports from outside Europe about improper manufacturing methods and missing or inadequate quality controls. This allows defective and potentially harmful medicines to be brought to markets. The study shows that by contrast, HMPs in the EU and Germany meet the same rigorous standards for safety and quality as all other medicinal products. Therefore consumers can be sure that they always receive officially monitored, high quality medicinal products.

For further information

• Pharmaceutical Quality of Homeopathic Medicinal Products, Orth et al, Pharm. Ind. 83, Nr 1, 74–83 (2021)