EP, USP and JP

There are three major regional pharmacopeia organizations. They are responsible for the preparation and publication of pharmacopoeial editions. These pharmacopoeias cover commonly used prescription and over-the-counter medicines, as well as food supplements, excipients and other health products manufactured and sold.

  • The European Directorate for the Quality of Medicines (EDQM) - responsible for the European Pharmacopoeia (EP)

  • The United States Pharmacopoeia Convention - responsible for the United States Pharmacopoeia (USP).

  • The Japanese Ministry of Health - responsible for the Japanese Pharmacopoeia (JP).

The texts of the European Pharmacopoeia deal with the following points: The qualitative and quantitative composition of medicinal products, the tests to be carried out for the medicinal products, the raw materials used in the manufacture of the medicinal products and the semi-finished products manufactured. In addition, this pharmacopoeia contains texts on substances, excipients and preparations of chemical, animal, human and plant origin for pharmaceutical use, on homeopathic products and preparations, antibiotics, and on dosage forms and owners of medicinal products. Other items covered are biological preparations, blood and plasma derivatives, vaccines and radiopharmaceutical preparations. The texts of the European Pharmacopoeia are legally binding.

The United States Pharmacopoeia Convention is a scientific non-profit organization that establishes standards for the identity, action, quality and purity of drugs, food ingredients and dietary supplements manufactured, distributed and ingested worldwide. The USP contains texts on active ingredients in medicinal products, dosage forms and compounded preparations. The Food and Drug Administration (FDA) is responsible for meeting USP standards in the United States. The standards are developed at the USP and are used in over 140 countries. USP standards are recognized in a number of U.S. federal laws.

While the USP is not a governmental organization, it works closely with government agencies, ministries, and legislatures around the world to establish standards for the identity, potency, quality, and purity of drugs to ensure the quality of medicines, dietary supplements, and food ingredients. USP standards are recognized in laws or accepted as a means of meeting certain regulatory standards in several other countries. In addition, many governments and international regulatory agencies have incorporated them into their laws and regulations to ensure the quality of products and ingredients manufactured in or exported to other countries.

The Japanese Pharmacopoeia (JP) is a book of official pharmaceutical standards applicable in Japan, established by the Pharmaceuticals and Medical Devices Agency (PMDA) Secretariat and endorsed by the Japanese Ministry of Health and Labour.

The JP contains the official standards required in Japan to ensure the quality of pharmaceuticals in light of advances in science and technology and ever-increasing requirements. The JP contains standards for the specifications of medicinal products. It also describes testing methods that can be used to guarantee the quality of all medicines. The JP also plays an important role in determining the quality criteria considered essential for public health and medical treatment.

The JP is evaluated by expert committees at regular meetings held by the JP Secretariat. The JP was first published in 1886 and implemented the following year. The JP is revised on a regular basis. The 16th edition of the JP has been in effect since April 2011 by virtue of Japanese Ministerial Notice No. 65.

Source: APG Europe GmbH

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