【MHLW】 Exceptions to requirements for the appointment of general manager – An alumnus of pharmaceutical or chemical course

2020年11月11日 (水)

The Ministry of Health, Labor and Welfare (MHLW) have announced a draft ministerial ordinance regarding the partial revision under the amended Pharmaceutical and Medical Devices Act (PMD Act), which will affect August 1, next year. As the standard that allows technicians other than pharmacists to be assigned as General Manufacturing and Sales Manager, those who have completed a specialized pharmaceutical or chemical course are stipulated. In that case, a pharmacist will be designated as an assistant, and necessary measures will be taken to set a pharmacist as the general manager. From now on, opinions regarding this revision will be solicited, and that will be promulgated in late January next year.

The amended PMD Act is clear that it makes mandatory to establish a system for legal compliance, a full-time officer responsible for pharmaceutical affairs is legally positioned, and the responsibility of the general manager is clarified. The requirements to appoint a general manager had been limited to pharmacists. However, with this amendment of the PMD Act, an exception is established to appoint a person other than a pharmacist only if it is impossible to find a pharmacist who can fulfill the general manager’s responsibility.

In the draft ministerial ordinance, the standard of general manager should be “a person who has the ability to properly and smoothly carry out operations related to quality control of pharmaceutical products and post-marketing safety management.” and “a person who has been engaged in quality control, post-marketing safety management work, etc. for 3 years or more.” in the case of the first-class marketing license for pharmaceuticals and business licenses.

In case of appointing a person other than a pharmacist, a person who completed a specialized pharmaceutical or chemical course at universities or others, otherwise a person was approved by MHLW as who have knowledge and experience which is equal or higher than that of a person who completed a specialized pharmaceutical or chemical course.

In addition, it is required to establish a human resources development system as necessary steps for appointing a pharmacist who can help the general manager and further appointing a pharmacist as the general manager. It is also clear that when applying for permission of a general manager position or filing a change notification, the person must submit documents stating the reasons for assigning a technician other than the pharmacist and plans and so on which regarding the actions required to set pharmacists as general manager.

Regarding medical gases, against only medicines designated by MHLW, a technician other than a pharmacist can be appointed as the general manager or manufacturing manager. So far, oxygen, carbon dioxide, etc., have been determined. But in the future, the Minister of Health, Labor and Welfare’s notification will specify ethylene oxide and so on.

It also obliges the establishment of a legal compliance system and stipulates the operations performed by Marketing Authorization Holder (MAH), manufacturers, pharmacies, store distributors, wholesale distributors, as well as matters of concern. MAH must maintain a copy of the opinion by the general manager, and manufacturer maintain a copy of the opinion by manufacturing manager and responsible technician for five years. Pharmacies and others must keep copies of documents containing comments against pharmacy founders and distributors for three years. 

It is also clear that MAH and manufactures should instruct and supervise for manager of quality assurance and safety management, and the pharmacy founder should instruct and supervise for pharmacists and registered sellers.

By the amended PMD Act, the “system of responsible officers” that officers are responsible for regulatory matters such as approval applications and manufacture & sales and others has been placed under the PMD Act. Based on that, it will be required for clarification of the responsible official’s authority, and also making mandatory of an education and training/evaluation system for responsible officers and employees responsible, and formulation guidelines of legal compliance for employees.

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