Laws and regulations

MD Pharma Consulting Group

Founder of Healthcare Business Solutions

Regulatory Affairs

1- Regulatory Roadmap

MD Pharma Consulting Group provides regulatory roadmaps for Egypt and countries of the MENA region. Topics included in the regulatory map include but are not limited to:

  • Recommend product classification and suggest process, timeline, fees, requirements, etc.

  • Acceptance of national approvals in Egypt and countries of the MENA region.

  • Specific local requirements (Good Manufacturing Practice Clearance, Risk Management Plan, etc.) to support product registration.

  • Review existing data and determine the New Drug Application submission pathway with insights of eligibility of expedited pathways, evaluation process, fees, timeline, requirements, etc.

  • Marketing Authorization Holder responsibility and transfer procedure, timeline, fee, etc.

 

2- Product  classification, Gap analysis, and Module 1 preparation

Guided by MD Pharma Consulting Group's gap analysis, our regulatory affairs experts will review and offer advice on identified gaps between the current dossier and local requirements, justify product classification requirements and confirm with Health Authority as necessary, provide guidance, checklist, and available templates of Modules 1-5 of New Drug Application submission, and evaluate and provide feedback on existing evidence to prepare for Module 1 of submission to each Local Health Authority (application forms, requests, and letters, etc.) in accordance with requirements by Local Health Authority.

3- Marketing Authorization Holder Support for Submission of New Drug Application

Based on MD Pharma Consulting Group's market research, our regulatory affairs experts will deliver customized support to the marketing authorization holder and takes the marketing authorization holder's responsibilities for the submission of new drug application. This includes but is not limited to:

  • Validation of the whole package for submission.

  • Review the submission package and perform quality control of completeness of information before submission for resource optimization and allocation.

  • Fulfill pending clarifications to provide advice on what other information could be provided or further rationale to be provided to the Local Health Authority.

  • Represent client as the local entity and finalized New Drug Application submission to the Local Health Authority.

  • Submit and follow up till regulatory approval.

  • Strategize responses with the client based on the understanding of queries from the Local Health Authority and consult the evaluator as needed.

  • Review the response document from the client and provide guidance if the response is not clear.

  • Submit the response document to the Local Health Authority.

4- Marketing Authorization Holder Support for Product Life Cycle Maintenance

Based on MD Pharma Consulting Group's market research, our regulatory affairs experts will deliver customized support to the marketing authorization holder and takes the marketing authorization holder's responsibilities for post-approval support and product life cycle maintenance. This includes but is not limited to:

  • Represent the client as the local entity and submits all regulatory applications as needed.

  • Submits and follows up till regulatory approval.

  • Discuss with the Local Health Authority evaluators and understand the potential risk and concerns.

  • Supports the client as the local liaison with Local Health Authorities, available for any in-person submission of hard copy documents or local payment of fees.

  • Manages any local testing or validation of test methods by the Local Health Authority or their designated laboratories (if applicable).

  • Annual Marketing Authorization Holder support activities such as Pharmacovigilance activities, safety reports, and other reporting requirements, including having an official local Qualified Person responsible for Pharmacovigilance officer as required by local legislation.

  • Assessment of post-approval changes (Clinical, Safety, Chemistry, Manufacturing, Controls, etc.) and provides regulatory assessments as needed.

  • Submits application of variation or renewal if applicable.

  • Keeps the client updated on new local regulations that may have an impact on their business and post-approval changes.

  • Prepares for Marketing Authorization Holder transfer application as needed.