Company: TAK
Filing Date: 2025-06-25
Form Type: 20-F
Source: 0001395064-25-000095
Chunk: 79

Company: TAKEDA PHARMACEUTICAL CO LTD
Filing Date: 2025-06-25
Form: 20-F
Item: Item 4
Chunk 79
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 to market pharmaceutical products in the EU Member States: the Centralized route and a national route. The national route includes the Mutual Recognition Procedure (the “ MRP”) and the Decentralized Procedure (the “ DCP”). It is also possible to obtain a pure national authorization for products intended for commercialization in a single EU Member State only.

Under the Centralized Procedure, applications are made to the EMA for an authorization which is valid throughout the EU, as well as in Iceland, Liechtenstein and Norway. The Centralized Procedure is mandatory for human medicines containing a new active substance to treat cancer, neurodegenerative disorders, diabetes, AIDS, autoimmune diseases or other immune dysfunctions, viral diseases, medicines derived from biotechnology processes, advanced therapy medicines, and orphan medicines. It is optional for other medicines containing new active substances for indications other than those stated above or if there is a significant therapeutic, scientific or technical innovation or if in the interest of public health. When a pharmaceutical company has gathered data which it believes sufficiently demonstrates a drug’s safety, efficacy, and quality, then the company may submit an application to the EMA. The EMA then receives and validates the application, and the Committee for Medicinal Products for Human Use (the “ CHMP”) appoints a Rapporteur and Co-Rapporteur to lead review of the dossier. The entire review cycle must be completed within 210 days, although there is a “clock stop” at day 120, which allows the company to respond to questions set forth in the Rapporteur and Co-Rapporteur’s Assessment Report. After the company’s complete response is submitted to the EMA, the clock restarts on day 121. If there are further aspects of the dossier requiring clarification, the EMA will then request an Oral Explanation on day 180, in which case the sponsor must appear before the CHMP to provide the requested additional information. On day 210, the CHMP will then take a vote to recommend the approval or non-approval of the application. The final decision under this Centralized Procedure is a European Community decision which is binding in its entirety on all EU Member States. This decision occurs on average 60 days after a positive CHMP recommendation. In the case of a negative opinion, a written request for re-examination of the opinion can be made by the applicant within a time limit of 15 days from the date of the opinion. The detailed grounds for re-examination must be submitted to the EMA within 60 days