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:

What is a gas?

What is a gas?

You can view the answer here:
Read more
EMA: Pilot Programme for Breakthrough Devices

EMA: Pilot Programme for Breakthrough Devices

The EMA plans to launch a pilot programme in Q2 2026 to implement the guidance for breakthrough devices issued in December 2025.

Read more
EDQM: New Ph. Eur. Chapter on Data Quality with a Focus on Digital Data

EDQM: New Ph. Eur. Chapter on Data Quality with a Focus on Digital Data

The European Pharmacopoeia (Ph. Eur.) has introduced a new general chapter that provides a framework for managing the quality of data, including digital data, throughout its life cycle.

Read more
PIC/S: Jordan FDA Joins PIC/S

PIC/S: Jordan FDA Joins PIC/S

On 1 January 2026, the Jordan Food & Drug Administration (JFDA) became the 57th PIC/S Participating Authority.

Read more
Swissmedic: Scientific GMDP Meetings

Swissmedic: Scientific GMDP Meetings

Swissmedic offers companies holding or seeking a Swissmedic manufacturing or distribution license the opportunity to discuss project-specific GMP and GDP topics in Scientific GMDP Meetings.

Read more
Purified Water – The new Chinese Pharmacopoeias and What Happens Next?

Purified Water – The new Chinese Pharmacopoeias and What Happens Next?

A new Chinese Pharmacopoeia was published in 2025. This has some significant implications for the pharmaceutical water industry, which we will discuss in more detail in this article. Firstly, it is important to note that cold WFI systems are now permitted worldwide and can be used across the board.
Read more
Previous
Next