CDIMRevision of the Pharmaceutical Machinery Law (Part 2)
It is the second part of the revised column on the drug machine law. This time, we will explain the outline of the revised items and the implementation schedule.
〇Outline of legal amendments
For the background and purpose of such legal revisions, the following is a summary and points to note regarding specific items to be revised. Details of each amendment will be explained in the next and subsequent articles.
1. Improvement of systems to provide medicines, medical devices, etc. more safely, quickly and efficiently
(1) Legalization of the "pioneering examination designation system"
The priority examination target of the pioneering examination system, which has already been notified and operated since 2015, has a clear mechanism of action compared to already approved
It is classified into “pioneering drugs, etc.” that are different, and “special-purpose drugs, etc.” that do not meet medical needs,
It will be clarified as a legal system.
"Special-purpose drugs, etc.", which is a new category and has tax incentives, will be the focus of attention.
(2) Legalization of "conditional early approval system"
The conditional early approval system, which has already been informed since 2017, has difficulty in conducting confirmatory clinical trials.
, Etc. are subject to conditions at the time of approval after confirming their efficacy and safety based on data from clinical studies other than confirmatory clinical trials.
It will be legislated as an approved system.
In 2013, regenerative medicine products were expanded, target products were expanded in 2017, and legislation was introduced.
(3) Change of approval items according to change plan, introduction of internationally consistent quality control method, etc.
Addition of a system for changing approval items based on the post-approval change management plan for approval items related to manufacturing methods and quality of pharmaceuticals,
Regarding the manufacturing control and quality control of pharmaceuticals, etc.QMS compatibility survey for medical devices
Re-evaluation to eliminate the need for the same survey at the manufacturing plant that performs the same manufacturing processWill be
It is expected that efficiency will be improved by changing the approval items according to the change plan and reviewing the manufacturing/quality control survey.
(4) Introducing a medical device approval system to respond to continuously improving and improving medical devices and technological innovation
Change plans for medical devices that are expected to be continuously improved due to data collected after marketing are reviewed
An approval examination system will be introduced to confirm and allow partial changes to the approved items within the planned range.
It is expected to support medical devices with improved performance that utilize AI and RWD (real world data).
(5) Principle of provision of package insert by electronic method to promptly provide the latest information to medical practice
The package insert is no longer included in the product, but is basically provided electronically. In addition, the latest package insert information
There is a mechanism to ensure that information that can be accessed (QR code etc.) is displayed on the outer box of the product to ensure that the revised information reaches medical institutions.
Will be built.
It is required to establish the necessary system so that the information on the package insert can be effectively delivered to the medical field.
(6) Mandatory display of barcodes, etc. on the packaging of pharmaceutical products to improve traceability
Management of information on pharmaceuticals, medical equipment, etc., tracking of usage records, from manufacturing and distribution to medical practice
In order to prevent mix-ups, it is obligatory to display barcodes on the direct containers and packaging of medicines, medical equipment, etc.
By managing barcodes, in addition to preventing drug mix-ups, etc., it also utilizes data analysis by converting usage records into big data.
Expected
2. Review of pharmacists and pharmacies so that patients can use medicines with peace of mind in the community
(1) Obligation of the pharmacist to grasp the patient's drug usage status as necessary and to provide patient compliance instructions, and patient drug usage information.
Legislation of effort obligation to provide to doctors, etc. at other medical care facilities
Information and guidance based on pharmaceutical knowledge when selling/awarding patients who have purchased the current dispensed drug
In addition to the duty of taking medication, it is also obligatory to take medication after dispensation and to keep track of the medication status.
In addition, information on the use of drugs by patients can be provided to doctors, etc. at other medical facilities to promote cooperation among medical facilities.
It is an obligation to make an effort.
Not only products (medicines), but pharmacists are required to have information on people (patients) and management expertise.
(2) Introduction of a function-based pharmacy governor certification system that enables patients to select the pharmacy that suits them
Regarding the role of pharmacies, pharmacies that can centrally and continuously respond while coordinating information with medical institutions and with local pharmacies
("Regional cooperation pharmacies"), pharmacies capable of cooperating with related organizations for specialized pharmaceutical management of cancer ("specialized medical institution cooperation drugs"
Each name label is introduced to the pharmacies that are recognized as having the function of "bureau" by the approval of the prefecture.
In addition to health support pharmacies, acquire regional pharmacies, specialty medical institution pharmacies, and how to utilize them.
Is a challenge.
(3) Medication guidance by videophone etc. as an exception to face-to-face obligation(Online medication instruction)Regulations
Regarding face-to-face medication guidance by pharmacists for patients who purchased the dispensed drug, etc.
When it is recognized that the use can be secured, as an exception to face-to-face medication instruction, medication instruction by videophone etc.
It will be possible.
Attention will be paid to how much deregulation of online medication instruction can be accepted as well as online medical treatment.
3. Establishment of legal compliance system, etc. of related businesses to secure trust
(1) Obligation of establishment of legal compliance system for licenses etc.
For manufacturing/marketing companies/manufacturers, pharmacists, etc., set up officers responsible for pharmaceutical affairs, quality control, manufacturing/sales
Post-safety management, establishment of guidelines and systems for legal compliance in the management of pharmacies, and ability and experience necessary for legal compliance
The law stipulates the appointment of manufacturing and sales managers/manufacturing managers, pharmacy managers, and the obligation of those persons to make opinions.
Will be done.
Corporate governance is required to comply with the regulatory requirements of pharmaceutical affairs, and it requires considerable cost to establish and operate the system.
(2) Creation of a levy system for sales of pharmaceutical products by false and hype
Violation of a false or exaggerated advertising act related to the name, manufacturing method, efficacy/effect or performance of drugs, medical devices, etc.
A system will be introduced that imposes 4.5% (with exceptions) of the sales amount of the drug, etc. during the period in which the service was conducted.
Currently, fines for false advertising violations are less than 2 million yen, especially for violations of drugs with large sales.
Sanctions are strengthened.
(3) Legislation of confirmation system for import of domestic unapproved medicines
The confirmation system (drug supervision certificate system) for monitoring the import of unapproved drugs and medical devices, etc., which is operated under the current notification
It will be legalized. In addition, for violations, guidance and enforcement will be carried out based on the Drug Machine Law, and it will be investigated by drug enforcement officers etc.
It is said that.
It is strengthening the crackdown on the misuse of personal imports, which is an exception to the pharmaceutical regulation of selling and awarding pharmaceutical products by licensed business.
(4) Introduction of a permit system for importing stimulant raw materials used as pharmaceuticals for the purpose of self-treatment
Regarding stimulant raw materials used as pharmaceuticals, similar to narcotics, patients import and export mobile phones for the purpose of treating their own illnesses.
It is possible to dispose of prefectural staff at medical institutions and pharmacies without witnessing. However, necessary items at medical institutions and pharmacies
Is required to be recorded.
It is a mitigation measure for the entry and exit of mobile phones for the treatment of Parkinson's disease that uses stimulant raw materials.
4. Other
(1) Establishment of a Pharmaceutical Evaluation and Surveillance Committee to evaluate and monitor measures such as ensuring the safety of pharmaceuticals
Evaluate and monitor the implementation status of measures for ensuring the safety of medicines and preventing the occurrence and spread of harm, and
The Ministry of Health, Labor and Welfare will establish an Administrative Evaluation and Surveillance Committee for Pharmaceuticals, which provides opinions and recommendations to the Minister of Labor.
This is a measure based on the recommendation "Revision of drug administration to prevent recurrence of drug damage" in case of drug hepatitis incident.
(2) Relaxation of restrictions on blood collection based on the development of science and technology (Blood Law)
Restrictions such as the use of medicines for testing purposes and blood collection for the purpose of contributing to the improvement of medical quality and health will be relaxed. Also,
Criteria for blood collection business have been clarified, and the blood collection business permission has been changed from blood collection site units to business unit
That responsibility will be clarified.
This is a review of the system for the development of science and technology such as the research and development of blood-derived iPS cells and changes in the situation surrounding the blood business.
* Timing of revision enforcement
As mentioned above, all amendments will be implemented over three years, but the implementation date was announced by the Cabinet Order in March of this year as follows. What is shown).
1. Effective date: September 1, 2nd year of Reiwa
Legalization of "pioneering examination designation system", legalization of "conditional early approval system"
"Introduction of medical device approval system for continuously improving and improving medical devices and technological innovation"
“Obligation of the pharmacist to grasp the patient's drug usage status and to provide patient compliance instructions, and patient drug usage information to other medical institutions
Legislation of obligation to make efforts to provide doctors, etc. at facilities
"Regulations for medication instruction by videophone (online medication instruction) as an exception to face-to-face obligation"
"Lawization of confirmation system for import of unapproved drugs in Japan"
"Introduction of a permit system for importation of stimulant raw materials used as medicines for self-treatment"
"Establishment of a Pharmaceutical Evaluation and Surveillance Committee to evaluate and monitor measures such as ensuring the safety of pharmaceuticals"
"Relaxation of blood collection restrictions based on the development of science and technology (Blood Law)"
2. Effective date: August 1, 3rd year of Reiwa
"Change of approval items by change plan, introduction of internationally consistent quality control method, etc."
(The review that made it unnecessary to carry out the same survey at the manufacturing plant that performs the same manufacturing process took effect on September 1, 2019.)
"Principle of provision of package insert by electronic method for prompt provision of latest information to medical practice"
"Introduction of a function-specific pharmacy governor certification system that enables patients to select the most suitable pharmacy"
"Obligation of contractors to establish legal compliance system"
"Establishment of a levy system for sales of drugs, etc. by false and hype advertising"
3. Effective date: December 1, 4th, Reiwa
"Obligation to Display Bar Codes, etc. on Pharmaceutical Packaging for Improved Traceability"
This time, I have explained the outline of the items to be amended and the time when the amendments will take effect. From the next time, we will explain each revised item.
Author: Tokuya Okanouchi
All rights reserved for this column.
Tokuya Okanouchi (CDI Medical Co., Ltd.)
静岡県立大学大学院薬学研究科修了、マサチューセッツ大学ビジネススクール修了。
博士（薬学）、経営学修士。
After working at the Ministry of Health, Labor and Welfare, the National Hospital Organization, the Pharmaceuticals and Medical Devices Agency, the National Institute of Health Sciences, the Ministry of the Environment, the Ministry of Justice, and Kanagawa Prefecture.