Submission of an updated Risk Management Plan (RMP) to TGA (Therapeutic Goods Administration) Australia

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 module 1.0.1 and the updated RMP in module 1.8.2.

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Making Submissions Related to Human Medicines to the MHRA in a No Deal Scenario

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 no deal scenario.

The MHRA is making preparations to ensure that in the event they leave the EU with no deal, you can continue to submit regulatory and notification information to the UK

Before getting started – guidance
Three short video demos are provided below which cover all aspects of the user access management process – these steps will enable your organization to gain access and manage user permissions for using MHRA Submissions.
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Electronic product information (ePI) for human medicines in the EU

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 of electronic tools to improve access of patients and healthcare professionals to product information in the EU. Electronic formats bring new opportunities for summary of product characteristics and package leaflets.

For more detailed information on draft key principles for ePI refer below link.

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/electronic-product-information-human-medicines-european-union-draft-key-principles_en.pdf

Jordan Food & Drug Administration (JFDA) started eCTD submissions

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 eCTD) Module 1 eCTD Specification current version 1.0.2.

Please visit JFDA’s website at http://www.jfda.jo for the further reference.

Electronic Submissions Gateway-New Ticketing Interface

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 to esghelpdesk@fda.hhs.gov to create tickets and receive response from ESG Help Desk.
2. ESG users may also submit tickets directly to the FDA via https://esghelpdesk.fda.gov.
3. Sending an email to esghelpdesk@fda.hhs.gov automatically creates a new account for each “from” email address. If you have previously communicated with esghelpdesk@fda.hhs.gov then your account already exists in the system and you do not need to send another email to create account.]

For further information please refer:
https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm