Pharmaceuticals are considered as the most highly regulated industries worldwide. The regulatory body ensures compliance in various legal and regulatory aspects of a drug. The major challenges of these regulatory agencies and organizations around the world are to ensure the safety, quality and efficacy of medicines and medical devices, harmonization of legal procedures related to drug development, monitoring and ensuring compliance with statutory obligations.
Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines addressing country-specific challenges:
- To regulate the drug development process, licensing, registration, manufacturing, marketing and labeling of pharmaceutical products.
- To ensure the safety, efficacy and quality of drugs, accuracy and appropriateness of the drug information available to the public
Regulatory bodies provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to individuals around the world.
Frequent changes in regulations by leading regulatory authorities have increased the significance of regulatory compliance management for drug manufacturers. Pharma companies across the globe are compelled to realign their quality and compliance structure to conform to the constantly evolving regulatory guidelines.
Working Path Prospective with Regulator’s & GOI:
Council for Healthcare and Pharma is a Not for Profit think-tank and advocacy group. Our objective is to support the vision of Universal Healthcare through standardisation, improvement and access to high-quality health products and systems, by enhancing availability, affordability and accountability.
Our highly experienced Regulatory Professionals at Council for Healthcare and Pharma provide detailed, yet non-exhaustive directions and services to Pharmaceutical Industry for Generic Drug products, Active Pharmaceutical Ingredients, Biosimilars and Healthcare for Medical Devices including life cycle management ranging from development to distribution through manufacturing, registration and approval.
- Regulatory Roadmap for Registration and Approval of Generic Products and Biosimilars across the Globe:
- Generic products are chemically synthesized products and are pharmaceutically identical (having same active ingredient) with respect to chemical composition and bioequivalent with the branded product / Reference Listed Drug (RLD) and are easy to develop because of less complexity.
- A biosimilar product is a biological product that is “highly similar” to and has “no clinically meaningful differences in terms of safety, purity, and potency” from an existing approved reference product. While a reference product is the single already-approved biological product based on a full complement of safety and effectiveness data.
- To facilitate the availability of Generic Drugs and biosimilars, CHP shall assist in identifying applicable Regulations, Guidance and Procedures for Registration and Approval of Generic Drug Products, Active Pharmaceuticals and biosimilars for US, Europe, Canada, Australia, Japan and Emerging Markets.
Regulatory Dossier Preparation / Review and Filing Submissions:
- Provide guidance for preparing Submission dossier / Preparation of Regulatory dossier (ANDA, MAA, DMF, CEP etc) in Common Technical Document format for US, Europe, Canada, Australia, Japan and Emerging Markets
- Due diligence of dossiers (ANDA / DMF) and evaluate manufacturing end data and associated quality data for adequacy while ensuring compliance with Global Regulations
- Respond to regulatory agency questions
Regulatory Strategy for Product’s Life cycle management of Generic Products (Dosage Form / API):
- Provide support for keeping ANDA, Marketing Authorization Applications (MAA) and DMF / CEP active by filing Annual Report / Annual Updates
- Revision of plans with change in Regulatory requirement / Guidelines
- Handling Post-approval changes in Drug Product and API for cost-competitiveness across the globe
- Major changes: PAS / Type 2 Variations
- Moderate changes: CBE 30 ( Changes Being Effected in 30 Days)
- Minor Changes (Annual Report)
Regulatory Roadmap for Registration and Approval of Medical Devices across Globe
- To support in the preparation of Regulatory Submissions for Medical devices (501k) across Globe.
Regulatory Strategy for early launch of product:
- US : 505 (b) (ii) in US (FTF launch)
- Europe : 3/5/6/10 years countries in Europe
Roadmap for Strengthening Pharma Industry for Ease-of-doing Business
- Global alignment of the regulatory expectations and perspectives and help the industry develop common knowledge.
- Facilitate interaction between Regulators and Industry Partners to address Industry issue with Government
- Provide support to keep abreast of the changes in the global regulatory environment as per company’s requirements of a particular region
Strengthening Pharma Industry for ensuring Compliance with Global Regulations for Sustainable Growth:
- Skill-building through training/workshops/seminars on Regulatory Requirements, GMP Compliance and Data Reliability.
- Implement GMP Compliance program for monitoring and ensuring conformance with the most common deficiencies observed by Global Regulators.
- Preparation, Training, and Inspection Readiness through an extensive range of training programs, mock inspections and other readiness solutions