Medical device manufacturing and sales industry, manufacturing industry, manufacturing and sales approval and certification
An easy-to-understand explanation of the key points of the 7 Pharmaceutical and Medical Device Act amendments
Updated: July 2026, 2
The Pharmaceuticals and Medical Devices Act (Act on Ensuring Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, etc.) was revised in 7. This revision significantly strengthens the supply system and quality control of pharmaceuticals and medical devices, and it is essential for everyone involved in the industry to take practical action.
In this article, we will clearly explain the background to the amendments and the main points that are directly related to practical application.
chief consultant Junya Yamada
Background and purpose of the amendment
This revision was made primarily to address the following issues:
The risk of pharmaceutical supply shortages is becoming apparent
The quality assurance system needs to be further clarified.
There is a need to create an environment that supports innovative drug discovery
Need for improved efficiency and convenience in pharmacy operations
In light of this situation, new obligations and mechanisms have been introduced in the Pharmaceuticals and Medical Devices Act.
Four pillars of the revision
1. Strengthening the quality assurance system for pharmaceuticals
Until now, the appointment of responsible persons has been carried out based on the GQP Ministerial Ordinance and the GVP Ministerial Ordinance, but this latest revision has made this clearly stipulated in the Pharmaceuticals and Medical Devices Act.
Appointment of quality assurance managers and safety management managers is now legally mandatory
The scope of responsibility has become clearer, and consistent management from manufacturing to distribution is required.
Manufacturers and distributors urgently need to reconfirm the roles of responsible persons and their internal structures.
2. Establishment of a stable supply system for pharmaceuticals
Addressing supply shortages has become a legal obligation.
Obligation to constantly monitor supply conditions
If shipments are halted or supplies are delayed, an immediate report must be made to the Minister of Health, Labour and Welfare.
The Minister can issue instructions to increase production of alternative drugs, adjust distribution, and limit the number of days for prescription.
In the future, it will be essential for each company to develop BCPs (business continuity plans) and supply risk countermeasures.
3. Improving the drug discovery environment
A mechanism has been introduced to support innovative drug discovery.
Establishment of a new fund to support drug discovery activities
In particular, support will be focused on the development of medicines for children.
For pharmaceutical companies, this will lead to increased R&D investment and new fundraising opportunities.
4. Strengthening pharmacy functions
This will greatly improve the efficiency and convenience of pharmacies.
Partial outsourcing of dispensing operations now possible
Progress in the introduction of remote sales by pharmacists
This is expected to improve the efficiency of pharmacy operations and provide highly convenient services for patients.
Summary
The 7 revision of the Pharmaceutical and Medical Device Act consists of the following four pillars.
Strengthening quality assurance system
Establishment of a stable supply system
Improving the drug discovery environment
Strengthening pharmacy functions
These amendments are intended to ensure the prompt and safe provision of medicines to the public.
Manufacturers, distributors, pharmacies, and pharmaceutical companies need to understand the purpose of the amendments and immediately begin reviewing their internal systems and business processes.
Future applications and notifications will also require you to comply with these amendments, so we recommend that you start preparing early.
