EP, USP and JP

A pharmacopoeia is an official compendium that sets out standards and requirements for the identity, purity, quality and dosage of medicinal products and their ingredients. These standards serve as the basis for the manufacture, testing and regulation of medicinal products and ensure that all pharmaceutical products are safe and effective.

Pharmacopoeias contain:

1. Monographs: Detailed descriptions of medicinal products, active substances, excipients and pharmaceutical products.

2. Analytical test methods: Standardized procedures for identification, purity testing and quantitative determination.

3. Manufacturing requirements: Guidelines for ensuring the quality of finished medicinal products.

4. Reagents and reference standards: Description of chemicals used and standards for analytical tests.

In the international pharmaceutical industry, the three most important pharmacopoeias are

- The European Pharmacopoeia (EP) in Europe,

- The United States Pharmacopeia (USP) in the USA,

- The Japanese Pharmacopoeia (JP) in Japan.

History and development

The European Pharmacopoeia was established in 1964 by the European Pharmacopoeia Treaty, which is under the auspices of the Council of Europe. Its first edition was published in 1969. The EP serves as a binding set of quality regulations for all member states of the Council of Europe and the European Union.

Structure and content

The EP contains monographs and methods that are relevant for the quality assurance of medicinal products, active substances, excipients and even packaging materials.

- Monographs: Describe chemical, biological and herbal medicinal products as well as medical gases and vaccines.

- Methods: Focus on state-of-the-art techniques such as chromatography, spectroscopy and microbiology.

- Standards for packaging: Requirements for primary packaging, such as glass, plastic and elastomers.

Significance for the industry

The EP is binding for the European pharmaceutical industry. Pharmaceutical manufacturers must ensure that their products and manufacturing processes comply with the EP specifications in order to obtain marketing authorization.

History and development

The United States Pharmacopeia was founded in 1820 and is one of the oldest pharmacopoeias in the world. It is published by the United States Pharmacopeial Convention, a non-profit organization. The USP is updated at regular intervals to keep pace with advances in science and technology.

Structure and content

The USP consists of two main parts:

- USP: Describes standards for drugs and active ingredients.

- NF (National Formulary): Contains standards for excipients.

It also includes standards for biological medicinal products, food supplements and medical devices.

- Analytical test methods: The USP emphasizes precise testing methods such as HPLC, GC and NMR spectroscopy.

- Monographs: Each monograph contains specifications on the identity, purity and potency of active ingredients and finished medicinal products.

Importance for the industry

The USP is required by law in the USA. Drugs that do not meet USP standards can be rejected by the FDA. In addition, the USP is also important outside the USA, as many international manufacturers produce products according to USP standards in order to gain access to the US market.

History and development

The Japanese Pharmacopoeia was first published in 1886 and is administered by the Japanese Ministry of Health, Labor and Welfare (MHLW). It is regularly updated to reflect new scientific and technological developments. The current edition is the 18th edition.

Structure and content

The JP is structured similarly to the EP and USP:

- Monographs: Contain standards for chemical and biological medicinal products and herbal remedies.

- Test methods: Focus on physical, chemical and biological tests, including modern technologies such as chromatography and spectroscopy.

- Reagents and reference standards: The JP places great emphasis on the availability of standards to support quality controls.

- Specialized tests: The JP includes specific tests tailored to the Japanese market, such as tests for traditional Japanese medicine (Kampo).

Importance for the industry

The JP is the legal basis for all pharmaceuticals marketed in Japan. Japanese manufacturers and foreign companies wishing to enter the Japanese market must comply with the JP standards.

1. Regional focus

- EP applies in Europe and is aligned with the EU and the Council of Europe.

- USP is primarily relevant for the USA, but is recognized worldwide.

- JP is specific to Japan.

2. Standards and test methods

- The standards and test methods are often similar, but there are regional differences in the requirements, e.g. for specifications or test methods.

- Some test methods are included in one pharmacopoeia but missing in others.

3. Regulatory implementation

- All three pharmacopoeias are binding for their regions.

- International companies often have to adapt products to the standards of several pharmacopoeias, which can lead to overlaps or discrepancies.

4. Innovations

- USP is a leader in introducing new testing methods for biologics and biotechnology products.

- EP emphasizes packaging standards.

- JP integrates specific tests for traditional Japanese medicine.

The existence of multiple pharmacopoeias leads to challenges for the global pharmaceutical industry:

- Cost: Companies often have to adapt their products to multiple standards, requiring additional testing and certification.

- Time: Discrepancies between pharmacopoeias can delay market access.

- Regulatory uncertainties: In some cases, regional differences can lead to confusion.

To solve these problems, the International Conference on Harmonization (ICH) is working to harmonize standards. Projects such as the Pharmacopeial Discussion Group (PDG) have already led to the harmonization of certain monographs and test methods.

The European Pharmacopoeia (EP), the United States Pharmacopoeia (USP) and the Japanese Pharmacopoeia (JP) are indispensable tools for ensuring the quality and safety of medicines. Although they each have a regional focus, they share the common goal of guaranteeing patients worldwide access to high-quality medicines. Harmonization of these pharmacopoeias remains a key aspect of improving the efficiency of the global pharmaceutical industry and overcoming the challenges posed by regional differences.