What is the Japan Pharmaceutical Affairs Law?

The Japan Pharmaceutical Affairs Law details the regulations that govern the pharmaceuticals, medical devices, and other healthcare equipment and products in Japan to ensure efficacy, quality, and safety.

There is a lot of confusion and misunderstanding about the regulations that govern the manufacture and sale of medical devices around the world. The Japan Pharmaceutical Affairs Law is designed to bring harmony to these requirements and bring guidance to manufacturers and distributors to ensure quality across the board. 

Introduction to the Japan Pharmaceutical Affairs Law

Do you have proper certification for your medical devices in Japan? It’s always a challenge when conducting business in another country because you must ensure you are compliant with their local laws. The Japan Pharmaceutical Affairs Law (JPAL) is the best example of this.

The purpose of the JPAL is to simplify the list of requirements that must be in compliance to and to eliminate conflicting demands from various quality management standards. In particular, this also encompasses the ISO 13485 in 2003. 

The JPAL also spans a wide range of laws and regulations such as but are not limited to the following: 

• Classification of devices
• Device approvals
• Marketing Authorisation Holder
• Clinical data
• Accreditation for foreign manufacturer
• QMS

The ordinance also breaks down the various steps that manufacturers need to comply with to ensure that it is within the scope of the Japan Pharmaceutical Affairs Law. The first section outlines the “General Rules” that determine the scope of the law and regulation. It also covers the design and development phase of the designated medical devices. 

The next step of the JPAL ordinance refers to the Quality Management System. If, in the event, that the manufacturer chooses to outsource the activities and processes involved in the manufacture of medical devices, the manufacturer is responsible for controlling such activities to ensure that it is accredited as a foreign manufacturer. There should also be an accompanying documentation that details the device specifications, installation, servicing, etc. 

The next section of the JPAL requirements refers to the management responsibility. There is a specific section in the JPAL that outlines the roles and responsibilities of an engineering manager and why it is vital in compliance.  Next is the Resource Management, wherein there should be an established and documented procedure to be followed for employees to ensure optimum work quality. Resource management applies to both staff and infrastructure involved in the manufacture of medical devices.

The Product Realisation is the real heart of the ordinance. This section outlines the elements, approaches, and controls that must be put in place to ensure the quality and efficiency in the manufacture and delivery of medical devices. Quality control begins from the acquisition of goods and supplies needed for the manufacture to the actual manufacturing procedure and the quality control of the manufactured products. 

Lastly, the final and most critical aspect of the ordinance is the Measurement, Analysis, and Improvement. This is where manufacturers need to focus on to ensure that measures for consistency, traceability, and continued improvement are put in place. 

Recommendations for Implementation

An understanding of the Japan Pharmaceutical Affairs Law (JPAL) is insufficient. You need to know how to successfully implement the ordinances to ensure compliance and quality assurance to the users and business partners.

Here are the recommended steps for implementation of JPAL to medical device manufacturers.

Step 1: Training.

It’s not enough that you know the ordinances stipulated under the Japan Pharmaceutical Affairs Law. It is important that you train your personnel to ensure that every level of the manufacturing process abides by the law’s ordinances. 

Step 2: Create an implementation plan.

Effective planning is vital in the successful implementation of JPAL. Conduct a gap analysis to determine if any improvement must be made from your current manufacturing standards to meet the ordinance. The gap analysis is a must to identify the areas where you need to improve on.

You must also identify your resources and it starts with allocating responsibilities and roles to various personnel across different departments. 

Step 3: Implement the QMS. 

Taking the ordinances of JPAL into account, you’re now ready to implement it into your quality management systems (QMS). This might require you to modify your existing processes to ensure you meet the existing requirements of the ministerial ordinances. 

During implementation, all levels of personnel must be involved – from top management. In fact, it requires top management involvement to ensure quality and consistency in the manufacturing process. 

Step 4: Internal Communication

If you modify the existing manufacturing processes to meet the specifications of JPAL, make sure to communicate that internally. Every member of your team must fully understand the changes to ensure effective adoption.

Step 5: Update internal audit.

You must also modify your internal audit procedures to match the changes you have implemented. Subject your internal auditor to additional training, if necessary.

Step 6: Undergo a pre-assessment.

A pre-assessment is an important step to ensure that you meet the JPAL requirements the first time. If not, you can make the appropriate changes to the rest of your manufacturing processes. 

Step 7: Schedule assessment.

Contact a local registration officer to determine if your QMS meets the standard of the JPAL. This could apply to a product or family of products.