The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique organisation consisting of representatives from the regulatory authorities in the European Union (EMA), Japan (MHLW) and the USA (FDA), and experts from the pharmaceutical industry in the three regions, in a single forum. ICH has concentrated on the preparation of the following quality related guidelines:

• ICH Q8 (R2) Pharmaceutical Development
• ICH Q9 Quality Risk Management
• ICH Q10 Pharmaceutical Quality System
• ICH Q11 Development and Manufacture of Drug Substances
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In the USA, the regulatory function is performed by the Food and Drug Administration (FDA) through two centers, the Center for Drug Evaluation and Research (CDER) in respect of medicines and the Center for Devices and Radiologic Health (CDRH) in respect of medical devices.

The FDA’s relevant current thinking for orally inhaled and nasal drug products is reflected in the following Regulatory Guidances for Industry:

In Europe, the Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency’s (EMA) committee responsible for human medicines.

The main guidance from the EMA relating to Orally Inhaled and Nasal Drug Products is contained in the following guidelines. These guidelines give a comprehensive list of the parameters that are critical to the safety, quality and efficacy of inhalation and nasal products:

• (CPMP 2006), Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products.
• (CPMP 2009), Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of asthma in children and adolescents.
• Matters relating to the “Replacement of chlorofluorocarbons in medicinal products” are also important considerations of quality, safety and efficacy.

In the UK, the Medicines and Healthcare products Regulatory Agency is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.

MHRA website

In China, the National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly the China Food and Drug Administration or CFDA). Its responsibilities include drafting laws and regulations for drugs, medical devices, and cosmetics, as well as establishing medical device standards and classification systems.

NMPA Website

In Brazil, the Health Regulatory Agency, Anvisa, executes sanitary control of the production, marketing and use of products and services subject to health regulation, including related environments, processes, ingredients and technologies.

ANVISA Website

In Canada, Health Canada reviews drug products to assess their safety, efficacy and quality.

Health Canada