A Strategic Framework for Tender Applications in the Generic Drug ROW Market 2.pptx

Tender application in the ROW market

1. A Strategic Framework for Tender Applications in the Generic Drug ROW Market Presented By Bhavesh Thorat (MRA 115) Guided By DR.P.P. Nerkar Sir Mr. Sonwane Sir Mr. Atul Patil Sir Mrs. Mihali Patel Mam Dept. of Regulatory Affairs, RCPIOP, Shirpur 1

2. INDEX 1.Introduction 2.Understanding The ROW Market 3.Requirement Tender Applications For Generic Drug 4.Registration Requirement For ROW 5.CMC Documents 6.Bidding Process Of Tendering Of Pharmaceutical ROW Market 7.Analysis Of Government Forecast Of Drug Demand 8.Potential Impact On Pricing, Competition Product Quality and Health-System Economics Associated With Tendering 9.List Of Medicines Tender Categories In South Africa 10.Market Research Importance 11.Regulatory Complies Strategies 12.Consideration In ROW Market Tender 13.Conclusion 14.Refrences 2

3. What is Tender ?.......... a tender is an offer or invitation to bid for a project or to accept a formal offer such as a takeover bid. This term usually refers to the process through which the government and financial institutions put forward invitation bids for large projects. These bids are to be submitted within a given deadline. 3

4. Introduction: Pharmaceutical tendering refers to the bulk purchase of medicines by A central buyer at fixed prices over specific periods. This is expected to reduce drug costs as a result of price competition, achieve economies of scale and scope for the buyer, and cut administrative inefficiencies that arise in fragmented distribution systems. The world health organization considers tendering to be a form of strategic purchasing of health care inputs, I.E. “Active, evidence -based engagement in defining the service-mix and volume, and selecting the provider-mix in order to maximize societal objectives. Pharmaceutical tendering argue it stimulates competition between generic drug firms and drives down drug prices to more accurately reflect costs of production. The strategic purchasing of medicines from pharmaceutical firms may promote universal health coverage and help ensure timely access to affordable pharmaceutical tendering argue it stimulates competition between generic drug firms and drives down drug prices to more accurately reflect costs of production. The strategic purchasing of medicines from pharmaceutical firms may promote universal health coverage and help ensure timely access to affordable medicines for patients. 4

5. Understanding the ROW Market: ROW, or Rest of the World, is a term used to describe emerging markets and developing economies that are outside of major pharmaceutical hubs. These markets include countries in Africa, Latin America, Eastern Europe, the Middle East, and parts of Asia, such as Brazil, Tanzania, Russia, and Hong Kong. ROW markets can be an opportunity for global manufacturers, offering a competitive edge, market size, and ease of approval. However, companies often don't include ROW markets in their global marketing strategies because they don't have the time or resources to focus on them. 5

6. Requirements Tender applications for Generic Drug Market: Tender application registration Regulatory compliance Strategies Cost Effective Analysis Quality Assurance Practices Health – System Economics Effective Communication Strategies Monitoring and Evaluation Documentation Requirements 6

7. Registration Requirements For Rest Of The World (ROW) Certificate of Pharmaceutical Product (COPP) Product permission Manufacturing License WHO-GMP Certificate Free Sale Certificate/Export Certificate Artwork ( Carton, Lable & Package Leaflet) 7

8. Drug Substance and Drug Product IUPAC Names CAS Number Nature of Drug substance Polymorphism and Chirality Description of Particle Size distribution, hygroscopicity, flowability, granularity 8

9. Chemistry Manufacturing And Control Documents AAPI DMF Open part- Following data should be available in open part Nomenclature General Properties Name of the Manufacturer and site of manufacture Route of synthesis, flow diagram in brief Structural Elucidation Impurities Specifications and method of analysis Container Closure System Stability testing- Retest period & Storage API Specification and method of analysis & COA od API by the applicant 9

10. Bidding Process Of Tendering Of Pharmaceutical ROW Market: The bidding process for tendering in the pharmaceutical Rest of the World (ROW) market involves several critical steps. Pharmaceutical companies participate in these tenders to supply medicines to various countries or regions. Here's an overview of the process: Tender Announcement Document Preparation Submission of Bids Evaluation of Bids Negotiation and Contract Award 10

11. Conti……….. 6. Contract Execution 7. Post-Award Compliance 11

12. 1. Tender Announcement Invitation to Bid: Governments, healthcare organizations, or procurement agencies announce tenders for pharmaceutical products. This announcement includes the specific requirements, quantities, timelines, and conditions. Pre-qualification: Some tenders may require pre-qualification, where suppliers need to demonstrate their capabilities before submitting a bid. 12

13. 2. Document Preparation Bid Documents: Companies prepare detailed bid documents, which include product specifications, manufacturing details, regulatory compliance, pricing, delivery timelines, and other relevant information. Regulatory Compliance: Bidders must ensure that their products meet the regulatory requirements of the country issuing the tender. This includes having necessary approvals, quality certifications, and adherence to Good Manufacturing Practices (GMP). 13

14. 3. Submission of Bids Technical Bid: Companies submit a technical bid that details the product's specifications, quality standards, and compliance with the tender's technical requirements. Financial Bid: A separate financial bid is submitted, outlining the pricing structure, payment terms, and any cost-related aspects. 14

15. 4. Evaluation of Bids Technical Evaluation: The tendering authority evaluates the technical bids to ensure they meet the required standards and specifications. Financial Evaluation: After technical evaluation, financial bids are opened. The lowest bidder (often referred to as L1) is usually preferred, provided their technical bid meets all requirements. 15

16. 5. Negotiation and Contract Award Price Negotiation: Sometimes, there may be negotiations on the price, especially if the tendering authority feels the price quoted is high Award of Contract: The contract is awarded to the bidder who meets the technical requirements and offers the most competitive price 16

17. 6. Contract Execution Supply Agreement: The successful bidder enters into a supply agreement with the tendering authority, which outlines the terms of supply, delivery schedules, penalties for non-compliance, and other contractual obligations Product Delivery: The supplier is responsible for manufacturing, packaging, and delivering the products as per the agreed timeline. 17

18. 7. Post-Award Compliance Regulatory Reporting: The supplier may be required to provide periodic reports on the product's performance, stability, and any adverse events Inspections and Audits: Regulatory bodies may conduct inspections and audits to ensure compliance with the contract and regulatory standards. 18

19. Analysis of government forecasts of drug demand The government declared in the tender contracts issued during this period, to the quantities the government went on to procure over the course of each contract. selected the tenders issued during years because of the availability of complete data for each contracted period. The focused on medicines in seven therapeutic classes: Angiotensin converting enzyme inhibitors, angiotensin receptor blockers, atypical antipsychotics, calcium channel blockers, proton-pump inhibitors, selective serotonin reuptake inhibitors, and statins. These medicines, which are some of the most widely consumed globally 19

20. Potential impact on pricing, competition, product quality, and health-system economics associated with tendering WHO for obtaining favorable pricing when purchasing drugs include supplier competition through open tenders, restricted tenders, or competitive negotiation.20 Direct negotiation with a single supplier is less likely to result in optimal pricing; therefore, it is recommended that this practice be limited to very small or emergency purchases.20 Open tendering, which does not require prequalification of suppliers, is most likely to result in the lowest prices, especially when many reputable suppliers are available and are likely to be interested in the contract 20

21. List of medicine tender categories in South Africa: 1. Anti-tuberculosis medicines 2. Anti-infective medicines ( i.e , antibiotic, anti-fungal, antiprotozoal, and anti-viral agents) 3. Family planning agents 4. Oncology and immunological agents 5. Diagnostic agents and contrast media 6. Small-volume parenterals and insulin devices 7. Drops, aerosols, inhalers, and inhalants 21

22. 8. Semi-solid-dose medicines (incl. powders) 9. Solid-dose medicines and transdermal patches 10. Biological preparations 11. Large-volume parenterals 12. Pharmaceutical liquids, alcohols, ethers, glycerin, and methylated spirits 13. Anti-retroviral medicines 14. Pharmaceutical packaging materials 15. Intravenous administration accessories 22

23. Market Research Importance: Conducting thorough market research allows you to identify potential opportunities and challenges in the ROW market. This knowledge can guide your application strategy and enhance your competitive edge. 23

24. Regulatory Compliance Strategies: Navigating regulatory compliance is vital for tender success. Develop a comprehensive understanding of local regulations and ensure all documentation is meticulously prepared to avoid delays. To successfully enter a ROW market, companies need to understand the regulatory landscape of each country. This includes researching local clinical trial protocols, product registration procedures, labeling specifications, and pharmacovigilance mandates. It's also important to build relationships with local regulatory authorities to navigate bureaucratic processes. 24

25. Key Considerations in ROW Market Tenders: Regulatory Differences: Each country in the ROW market may have different regulatory requirements, which can complicate the bidding process. Market Dynamics: Understanding the specific needs, pricing pressures, and competition in the ROW market is crucial. Supply Chain Management: Efficient management of logistics and supply chains is essential to meet delivery timelines and avoid penalties. Participating in tenders in the ROW market can be a complex process, but with careful preparation and understanding of the regulatory and market dynamics, pharmaceutical companies can successfully secure contracts. 25

26. Conclusion Tendering allows central buyers to aggregate drug demand across many patients and increases their leverage against companies. It can be an effective measure for securing low medicine prices on a sustainable basis. It may allow drug purchasers to achieve economies of scale and scope, realize administrative savings, and improve price transparency. 26

27. Reference WHO https://extranet.who.int/prequal/medicines/procurement-agencies https://extranet.who.int/prequal/inspection-services/notice-concern https://extranet.who.int/prequal/medicines/regulatory-agencies SAHPRA https://medapps.sahpra.org.za:6006/ https://ectd.sahpra.org.za/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3555014/ 27

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