Standards and regulation in the pharmaceutical industry 

Regulations

Many regulations are applicable to the pharmaceutical industry and its products. Here are a selection of the most important. 

European pharmaceutical strategy

It was proposed in 2023 to replace existing legislation with a new laws concerning how pharmaceuticals are licensed for use in the EU (EC communication 2023/192; EC communication 2023/193). Three of the main objectives are to ensure:

• Timely and equitable access to safe, effective, and affordable medicines.

• Medicines that are more environmentally sustainable.

• Antimicrobial resistance and the presence of pharmaceuticals in the environment is rectified.

Registration, Evaluation, Authorisation and restriction of CHemicals (REACH)

Since 2007, REACH has required EU manufacturers and importers of substances (over 1 tonne per year) to register vital information about the properties and hazards of those substances (Regulation (EC) 1907/2006). Due to an exemption, REACH is not directly applicable to active pharmaceutical ingredients (APIs), but it has an impact on the chemicals used to make APIs. Chemicals which are deemed to have unacceptable hazards to human health or the environment are placed on a list of Substances of Very High Concern, and then can be subject to regulatory controls. It is possible to effectively ban a substance (although permits can be acquired in some circumstances) or impose restrictions on its use. This has already happened to some solvents and metal salts relevant to the pharmaceutical industry. Where restrictions call for reduced exposure to a chemical, usually the health and safety practices in a pharmaceutical company are already sufficient to meet new guidelines (achieved via a combination of personal protective equipment and ventilation) (Sherwood et al., 2024).

Industrial and livestock rearing Emissions Directive (IED 2.0)

IED 2.0 is a revision to the earlier Industrial Emissions Directive (Directive (EC) 2024/1785). As a Directive, it is not a regulation in its own right, but by setting goals establishes the basis for EU member states to create and revise their national laws. The purpose of IED 2.0 is to implement best practice to reduce emissions, with stricter emissions limits imposed and an emphasis of resource efficiency.

Water framework directive

The Water Framework Directive was established to protect inland rivers and lakes, groundwater, and coastal surface waters (Directive 2000/60/EC). Broadly speaking, the purpose of this Directive is to ensure water is plentiful and not polluted. Regular water quality checks are made. Future legislation will implement a principle of 'extended producer responsibility', and companies will be held accountable for poor water quality arising because of their waste streams.

Pharmaceutical safety standards

The production and use of APIs is highly regulated to minimise any adverse health effects. As covered in the quality control segment, the major regulatory bodies are the European Pharmacopeia (EP), the European Medicines Agency (EMA), the United States Pharmacopeia (USP), and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH divide their guidelines into four categories:

• Safety for unforeseen health risks (e.g. carcinogenicity);

• Efficacy to ensure the accuracy of clinic trials;

• Quality to monitor impurities;

• Multidisciplinary covers specific testing standards and reporting.