What is the Pharmaceuticals and Medical Devices Act

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The Pharmaceuticals and Medical Devices Act is a law that aims to improve health and hygiene by maintaining the safety, functionality, and quality of pharmaceuticals, cosmetics, medical devices, etc.

Until the revision in November 2014, this law was known for a long time as the Pharmaceutical Affairs Law, but it is now called the Pharmaceutical and Medical Device Law, and its official name is the "Law on Ensuring Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, etc."

The Pharmaceutical and Medical Device Law is deeply involved in the sale of pharmaceuticals, and it is necessary to comply with it.

There are many things to keep in mind when delivering advertisements, so we will first provide a detailed explanation of the Pharmaceuticals and Medical Devices Act.



1.1 Purpose of the legislation

As mentioned above, the Pharmaceuticals and Medical Devices Act is a uk consumer email list law that aims to ensure the safety of pharmaceuticals and medical devices as well as improve public health and hygiene. The specific objectives of its enactment include the following:



Purpose of the legislation



・Regulation of specific drugs
・Preservation of public health
・Prevention of serious health and hygiene hazards

Medical products such as medicines and medical devices may have unintended effects on the body called side effects in addition to their main effects.

When dealing with medical products, it is necessary to properly evaluate their usefulness and safety. The Pharmaceuticals and Medical Devices Act exists as a law that fulfills such a role.





1.2 Items subject to the Pharmaceuticals and Medical Devices Act


The products subject to the Pharmaceuticals and Medical Devices Act include a wide variety of items related to our daily lives, but these products can be broadly categorized as follows:



Items subject to the Pharmaceuticals and Medical Devices Act



・Pharmaceuticals
, quasi-drugs
, cosmetics
, medical devices
, regenerative medicine, etc.　　

All of these products require prescriptions based on a doctor's diagnosis and safety measures after being marketed.

These safety measures include collecting information on side effects and defects, product recalls based on that information, sharing information with the general public, etc.

Also, there are products for which different regulations apply depending on the type, and in such cases, detailed understanding is required, such as whether clinical trials are required and whether approval is required for sales.