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DRUG REGULATORY AFFAIRS INTERNATIONAL
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ICH Q11 Q and A Document
The topic of starting materials has been a vexed topic for some period. Indeed concerns relating to lack of clarity and issues pertaining to practical implementation led the EMA in Sept 2014 to publish a reflection paper—Reflection on the requirements for selection and justification of starting materials for the manufacture of chemical active substances.(10) The paper sought to outline key issues as well as authority expectations; specific areas of interest identified included the following:
| 1. | Variance in interpretation between applicant and reviewer. |
| 2. | The registration of short syntheses that employ complex custom-made starting materials. |
| 3. | Lack of details preventing authorities being able to assess the suitability of a proposed registered starting material and its associated control strategy. |
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