Skip to main content Skip to search Skip to main navigation

Japanese Pharmacopeia with English Translation

The Japanese MHLW (Japanese Minister of Health, Labour and Welfare) has released the 18th Edition of the Japanese Pharmacopoeia (JP) as an English translation for download free of charge.

The 18th edition came into effect on June 7, 2021, and consists of

  • General Notices,
  • General Rules for Crude Drugs,
  • General Rules for Preparations,
  • General Tests, Processes and Apparatus and
  • Official Monographs
  • General Information

Being an official document, it defines the specifications, criteria and standard test methods necessary to properly assure the quality of medicines in Japan. The document is revised periodically with a further edition being planned for the year 2026.


Source:

MHLW: Website

PMDA:  Japanese Pharmacopoeia

Meet the GMP Compliance Adviser

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The demo access is non-binding and ends automatically.

Test it now for free

You may also be interested in the following articles:

Annex 22: EMA Workshop on AI in GMP

Annex 22: EMA Workshop on AI in GMP

The European Medicines Agency (EMA) will hold a two-day multistakeholder workshop on 30 June and 1 July 2026 to gather expert input for the development of Annex 22 of the EU GMP Guide on the use of artificial intelligence (AI) in medicines manufacturing.
Read more
FDA: Pilot Program for One-Day Inspectional Assessments

FDA: Pilot Program for One-Day Inspectional Assessments

Since April 2026, the U.S. FDA has been piloting “One-Day Inspectional Assessments” as a complement to standard FDA inspections.
Read more
EU: Commission Implementing Regulation on QM and Conformity Assessment Activities of Notified Bodies

EU: Commission Implementing Regulation on QM and Conformity Assessment Activities of Notified Bodies

Commission Implementing Regulation (EU) 2026/977 of 4 May 2026 further specifies requirements for notified bodies under the MDR and IVDR frameworks and aims to promote a more harmonised implementation across the European Union.
Read more
The ABC of User Requirements Specification (URS)

The ABC of User Requirements Specification (URS)

In the URS, the future user defines what the system should be capable of, but also what it is limited to. In addition to the (testable!) technical requirements, regulatory require-ments should also be taken into account.
Read more
What is the Importance of Data Integrity?

What is the Importance of Data Integrity?

Here's the answer:
Read more
EDQM: Updated Guideline on CEP Revisions and Renewals

EDQM: Updated Guideline on CEP Revisions and Renewals

The European Directorate for the Quality of Medicines & HealthCare has published a revised version of its guideline on the revision and renewal of Certificates of Suitability (CEPs) (PA/PH/CEP (04) 02), aligning it with recent EU legislation on variation procedures.
Read more
Previous
Next