The Regulatory Affairs Environment in Japan

Understand how to successfully navigate the Japanese health authorities and bring pharmaceutical products onto the Japanese market.

4. May 2022

3 days course


18,000 DKK ex VAT
(app. 2,420 EUR ex VAT)

Module 4


This online course will provide you with a thorough overview and in-depth case studies on how to successfully navigate the Japanese health authorities and bring pharmaceutical products onto the Japanese market. You will become familiar with the contents of drug dossiers, and the Japanese regulatory system, including the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labor and Welfare (MHLW). We will discuss the regulatory procedures throughout the drug development phases and how to successfully consult with PMDA, e.g., in the clinical trial notification phase.

You will get the latest trends in Japanese pharmaceutical regulations and procedures. You will receive lectures from senior Japanese regulatory professionals from industry, CROs and authorities.


  • Japanese pharmaceutical regulation
  • Japanese regulatory authorities
  • PMDA
  • Orphan Drug Designation (ODD) in Japan
  • Clinical trial notification, clinical studies and Good Clinical Practice (GCP) in Japan
  • Japanese new drug application
  • Chemical pharmaceutical documentation requirements (CMC)
  • Non-clinical and clinical documentation and requirements
  • Regulations for biologics and biotechnology products
  • Generic drug regulation in Japan
  • Pharmacovigilance
  • National Health Insurance (NHI) pricing
  • Patent and regulatory data protection

Hi! Do you need help choosing the right course?

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Whether you are new to the field or have several years of experience, this course is relevant if you are a Regulatory Affairs Professional who wants to improve your knowledge and skills

What you will learn

  1. To understand the Japanese drug development and post-approval framework and regulatory procedure
  2. The do’s and don’ts of constructive interactions with Japanese colleagues and officials
  3. How to successfully navigate the PMDA consultations
  4. How to play an important role in any project team working on obtaining a marketing authorization in Japan

What your company will get

  1. An employee who understands the Japanese drug development, post-approval framework and regulatory procedures
  2. A regulatory professional who can make recommendations on how to achieve project goals in the shortest possible development time
  3. A regulatory professional who is able to successfully navigate the PMDA consultations
  4. A regulatory professional who can play an important strategic role in project teams working on obtaining a marketing authorization in Japan

Course calendar

Starting 4. May 2022
4. May 2022 9:00-16:00


  • Japans overview, Regulatory Authorities
  • Early Access Programmes to the patiens
  • PMDA Consultations
  • Clinical Trial notification
  • Clinical Studies and GCP in Japan
  • Group Work

5. May 2022 9:00-16:00


  • Short summary of day 1 and introduction to day 2
  • Japanese New Drug Application
  • CMC for J-NDA and JAAF and CMC changes
  • Non-Clincial Documentation and Requirements
  • Labelling and safety reporting
  • Post Marketing Surveillance
  • Cultural Awareness Japan
  • Group work
6. May 2022 9:00-16:00


  • Short summary of day 2 and introduction to day 3
  • DMF
  • FMA
  • GMP Inspection
  • Generic Drug Regulation in Japan
  • Patent and Regulatory Data Protection
  • Group work
  • Rounding up and goodbye
Practical information

Related exams

3. Jun 2022 10:00-13:00
Go to exam page


Registration deadline
6. Apr 2022
Lersø Parkallé 101
2100 København Ø
Sometimes things change. This is the expected programme.

Course information


Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.

Please familiarize yourself with the mandatory readings before starting the course.

The mandatory readings are also part of the examination syllabus.


To enroll in this course, you must have a relevant educational background at bachelor level and, as a minimum, two years of experience in regulatory affairs, or other equivalent qualifications. We consider all applications upon registration.

If you do not fulfill the requirements, you can still apply for the course if you have experience in the pharmaceutical/biological area that would allow you to benefit from the training and enable you to participate actively during the module. Up to 10% of the positions on our course are filled by applicants who have no or limited experience in regulatory affairs. We consider applicants on a case-by-case basis.


The exam is usually held 4-6 weeks after the course. It is a digital exam, and you can therefore take the exam in your own country from any location that provides adequate internet access.

This course is a part of this programme

Regulatory Affairs Diploma

The regulatory affairs diploma gives you an understanding of the entire ‘regulatory affairs platform’ of the medicinal product lifecycle. All courses have been designed in collaboration with highly acclaimed experts, that are on our regulatory affairs faculty board

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WANT TO KNOW MORE or need help?

Contact Client Manager Mette Ribergaard Rasmussen at +45 39 15 09 30

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