Recommendation for Approval
Recommendation for Approval is a written report delivered by the Pharmaceutical Affairs Section of the Pharmaceutical Affairs and Food Sanitation Council (PAFSC) to the attention of the Minister of Health, Labor adn Welfare, who has the authority to grant approval (Shonin) for medicinal products in Japan. The Recommendation for Approval has no binding force and is designed to provide guidance to the concerned parties.
See also the entry for "Recommended" in Glossary - Stages in Approval Process
