Japan Market: Registration strategy development, documentation preparation, PMDA communication and coordination, GMP compliance guidance, post-marketing surveillance support.

Korea Market: MFDS registration submission, local testing agency coordination, documentation preparation, quality system certification guidance, adverse event report management.

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Japan Market

1.Definition and Background

Pharmaceutical registration in Japan refers to the approval process by the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW) to demonstrate drug quality, safety, and efficacy for market authorization.

As the world's third-largest pharmaceutical market, Japan adopts a "review-before-production" model, emphasizing authenticity of clinical trial data and compliance with localized production. Its regulatory requirements are stringent, with one of the most rigorous systems globally.

2.Applicable Scope

·Products: Chemical drugs, biologics, traditional medicines (including Kampo), vaccines, and some medical devices (may require joint applications).

·Applicants: Foreign companies must submit applications through a designated Japanese agent (DSP).

·Special Categories: Orphan drugs, national shortage drugs, and originator drugs qualify for accelerated approval pathways.

3.Basic Requirements

·Documentation: Clinical trial data (including Japan-specific data), CMC data, GMP compliance proof.

· Manufacturing: Sites must pass PMDA GMP inspections; processes must match registered details.

·Labeling: Japanese-language labels and package inserts must fully align with approved content.

4.Registration Process

1)Application submission (technical files: quality, non-clinical, clinical data)

2)Document review

3)Expert evaluation (may include on-site inspections)

4)Administrative approval (MHLW)

5)Post-marketing surveillance (periodic safety reports).

5.Regulatory Basis

·Pharmaceutical and Medical Device Act (PMD Act): Core regulations for registration procedures and standards.

·Drug Approval Standards: Technical review requirements and data submission formats.

·ICH Guidelines: Q-series (quality), E-series (efficacy), etc.

Korea Market

1.Definition and Background

Pharmaceutical registration in Korea requires approval by the Ministry of Food and Drug Safety (MFDS) under the Pharmaceutical Affairs Act and Medical Device Act.

Korea's fast-growing market aligns with欧美regulations, emphasizing localized testing and language adaptation. In 2024, MFDS strengthened import drug reviews and market surveillance.

2.Applicable Scope

Covers all drugs sold in Korea, including innovator drugs, generics, and biosimilars. Imported drugs require MFDS technical review; high-risk drugs may need additional clinical data.

3.Basic Requirements

·GMP Compliance: Manufacturing sites require Korean GMP certification or MFDS overseas inspection waivers (with proof).

·Documentation: Complete and accurate submission of manufacturing processes, ingredients, quality standards, stability data, etc.

·Compliance: Applications and products must adhere to Korean laws (e.g., registration regulations).

·Fees: Payment of application and review fees.

·Clinical Trials: If required, must follow MFDS protocols and submit data.

4.Registration Process

1)Prepare documents (product info, formulation, manufacturing process, QC standards, clinical data).

2)Appoint a local legal agent for MFDS communication.

3)Submit application (forms + documents).

4)Preliminary review (completeness check; requests for additional info if needed).

5)Pay registration fees (varies by application type/scale).

6)Technical review (quality, safety, efficacy evaluation).

7)Approval/registration (certificate issuance if compliant).

5.Regulatory Basis

·Core Laws: Pharmaceutical Affairs Act, Medical Device Act, MFDS Drug Safety Evaluation Guidelines.

·Import Rules: Imported Drug Management Regulations and Drug Distribution Standards.

·ICH Guidelines.