FDA defines Goal Dates for the Processing of Changes in Generics Authorisation Applications
The FDA is committed to compliance with certain deadlines for the processing of change applications and amendments in the approval process for generic drugs. Two recently published "Guidances for Industry" provide some information. Read more.
How can a CEP for a starting material be used in a CEP application for an API?
A CEP for a starting material offers several advantages, because it can be used for applying for an API CEP, which reduces the effort in the application process. However, this is linked to various conditions, which are described in a new document of the EDQM. Read more about this.
In which cases does the EDQM temporary suspend an existing CEP or definitively withdraw it? When can an ongoing CEP application procedure be closed? You can find answers to those questions in a new document of the EDQM. Read more here.
Stability Data for ANDAs in the USA: a new Q&A Document of the FDA provides further Clarity
The applicant for an ANDA in the USA has to submit data of several stability tests. The FDA guidance on this topic coming into force last year left open some issues, however, that now are clarified with a questions and answers document published lately. Read more.
New EMA Guideline on Stability Testing for Applications for Variations
The submission of a variations application for a marketing authorisation often includes the submission of stability data. This is particularly applicable to cases in which critical quality characteristics of the medicinal products are concerned. A new EMA Guideline sets rules to the requirements on different variations scenarios. Read more here.
New FDA Guideline on Size, Shape and Physical Attributes of Generics
Companies who want an authorisation for generic tablets or capsules in the USA should consider certain requirements with regard to the physical attributes of these dosage forms. The provisions can be found in a FDA Guidance for Industry recently published. Read more here.
Industry Proposals for Addressing Post-Approval Change Burdens Include Harmonizing on Commitments and Classifications
Biopharmaceutical firms are calling for a global effort to decrease their heavy post-approval change filing burdens that would clarify and harmonize change classification and submission requirements on a risk-based foundation. Read on.
"Reception denied!" - the new FDA "Refuse-to-Receive" Guidance for Generics Applications
Errors when compiling an application for authorisation for a generic drug in the United States can be really expensive. It is not only important to ensure the completeness of the documents, but also to pay attention to deadlines with regard to various fees. Learn more here.
Update: Electronic Submission of Marketing Authorisation Dossiers
Since the 1st of January 2010, only electronical submissions for marketing authorisations within the centralised procedure can be accepted. A few significant details about the procedure and the standards have been recently changed. Read more here about the current requirements for the electronical submission of dossiers.
The use of a black triangle-shaped warning symbol will be required as of January 2014 for drugs containing new APIs and biological products (including biosimilars) to enhance medicinal products safety. More information can be found in the News.
FDA publishes revised Guidance for Applicants of Marketing Authorisations for Generics
What do applicants for marketing authorisations of generic products absolutely have to observe is laid down in a FDA Guidance on fees and procedural issues within the framework of the Generic Drug User Fee Act (GDUFA). Read more on the topic.
EMA gives Clarification to the Variations Guideline in a Q&A Document
The EMA has published a Q&A document to clarify the questions still open with regard to the "detailed guidelines on procedure issues and the classification of variations" associated to the Variations Regulation. Read more here in the News.
"Sister File Procedure": New Fast-Track Procedure for the Application of Further CEPs for the Same API
How to apply for a second or third additional Certificate of Suitability for the same API? The EDQM has released a guideline on the topic. Read more about how the so-called "Sister File" procedure works.