Japan Drug Product Registration

MOH

Ministry of Health and Welfare  

Regulatory Authority

Pharmaceutical and Medical Device Agency (PMDA)

Regulatory Website  

https://www.pmda.go.jp/

Local Authorized Representative

YES

Classification of Drugs

1. Prescription Drugs 

Prescription medicines, also called prescription pharmaceuticals, are pharmaceutical compounds that can only be obtained lawfully with a prescription from a medical professional. Government agencies usually regulate these medications to guarantee that they are taken under the supervision of a licensed healthcare provider in a safe and efficient manner. Antibiotics:

Example: Amoxicillin

2. Branded Drugs

Pharmaceutical goods that are marketed and sold under a particular brand or trade name by the firm that developed and retains the patent for the drug are referred to as “branded drugs,” also known as “brand-name drugs” or “proprietary drugs.” Intellectual property rights, such as patents, trademarks, or other exclusive rights, typically safeguard these medications and grant the manufacturer and distributor exclusive rights to that specific formulation for a predetermined amount of time.

Example- Nexium (Esomeprazole)

3. Generic Drugs 

Pharmaceuticals known by their generic names are identical to those sold under brand names in terms of dose form, strength, administration method, quality, and intended use. These medications are made to have the same therapeutic effects as name-brand medications and contain the same active components. When the original brand-name drug’s patent protection expires, generic versions of the medication become available and are usually marketed using their chemical names rather than a brand name.

• Example – Metformin:

Generic: Metformin

Brand: Glucophage