A draft version of ICH Q12 (Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management) was issued in November 2017, and the goal is to have a final version by November of this year. A harmonised approach regarding technical and regulatory considerations for lifecycle management will benefit patients, industry, and regulatory authorities by promoting innovation […]
TGA has updated RMP for the sponsors of prescription medicines and biologicals making applications to enter or vary Australian Register of Therapeutic Goods (ARTG) entries. Therapeutic Goods Administration has provided form to be submitted along with updated RMP. Use this form when submitting an updated RMP after regulatory approval. This form should be submitted in […]
MHRA sets new process for Pharma Submissions if UK leaves the EU in a no deal scenario. Pharmaceutical companies and clinical trial sponsors were directed to follow new guidelines for regulatory submissions that would have to be directly submitted to the UK’s Medicines and Health products Agency (MHRA) if Britain leaves the EU in a […]
On 31 January 2019 the European Medicines Agency (EMA) published draft key principles for the development and use of electronic product information (ePI) for medicines for human use in the EU. Stakeholders and members of the public can submit comments using an online form until 31 July 2019. The European Commission, HMA and EMA are working together to facilitate the development […]
Moving towards to the paperless submission of dossier, JFDA has started accepting submission in eCTD format Following the same all initial marketing authorization submission from 01.03.2019, need to be submit in Jo-eCTD format. For other submission types an announcement will be published later (a Baseline for already approved marketing authorisations will be required) Jordan (JO […]
ESG will introduce a web interface to submit and access tickets to all ESG users. This new web interface will allow ESG users to submit tickets, view ticket updates, view the history of all tickets (including closed tickets), and access FAQs based on the ticket Request Type. 1. ESG users may continue to send emails […]
New Guideline Data Requirements for Human Drug Submission updated on 24-October-2017 Version 2.1 for GCC CTD. The Saudi Food and Drug Authority (SFDA) has updated its Gulf Cooperation Council (GCC) data requirements for human drugs submission. The data requirements for each application will differ, depending on the drug submission type and all the required data […]
Generic drug user fee makes it possible for FDA and industry to ensure that the public has access to safe and high quality generic drugs and drug products. The implementation of the Generic Drug User Fee Amendments (GDUFA) encompasses a wide range of activities that fall within the scope of regulating the generic drug industry. […]
ESG upgraded its Pre-Production WebTrader application to 2.0 version, which is also known as Phase 2 release. Upcoming ESG 2.0 – Phase 2 Release
The EU Module 1 eCTD Specification has been subsequently updated from version 3.0.1 to version 3.0.2 respectively. The following aspects are addressed: 1. Due to an update of the EMA procedural guidance regarding documents displaying tracked changes in PDF format inside an eCTD sequence the following sentence was deleted: “An exception to this rule is […]