DRUG APPROVAL PROCESS FOR CANADA,INDIA,EU,CHINA

[Audio] DRUG APPROVAL PROCESS FOR CANADA,INDIA,EU,CHINA.

[Audio] DRUG APROVAL PROCESS IN CANADA Health Canada, through the Health Protection Bureau (HPB), is the regulatory agency in Canada that oversees the evaluation and approval of pharmaceutical goods.[Botros, S., 2022] In Canada, scientists from the Health Products and Food Branch (HPFB) examine drug product applications. On occasion, specialists from outside Canada are also asked to evaluate the safety, effectiveness, and quality of a certain medication.[Zachariah, C. J.,2020] Therapeutic trial application (IND) for conducting clinical trials and new drug submission (NDS) for market approval are the two processes in the drug approval process..

[Audio] CTA permission is necessary whenever a sponsor wants to carry out human studies in Canada. APPROVAL PROCEDURE: Before a sponsor may market their new drug in Canada, they must submit an NDS (new drug submission) to Health Canada with HPFB. Along with preclinical and clinical study reports conducted in Canada or elsewhere, it contains all the information pertaining to safety, efficacy, and quality. Included must be all necessary documentation supporting the approval. To balance all the benefits and drawbacks of the drug, HPFB looks at the safety, efficacy, and quality data . Information submitted by HPFB was subjected to a rigorous evaluation by advisory committees and other specialists..

[Audio] A Notice of Compliance (NOC) and Drug Identification Number (DIN) are issued if the evaluation concludes that the drug's advantages outweigh its risks. This certifies the medication's official approval in Canada and gives the sponsor permission to sell it there. In order to verify the safety, efficacy, and quality of the drug product, the HPFB will test some biological products in labs using a procedure called the Lot Release Process (LRP)both before and after the authorization process. [Sandeep, D. S.,2019] Time line for approval – 6 months to 2 years.

[Audio] DRUG APPROVAL PROCESS IN INDIA In India drugs are approved by the Drugs Controller General (DCGI) and the Central Drugs Standard Control Organization (CDSCO). For clinical trials, the sponsor submits an IND to CDSCO. After completion of clinical trials applicant submit NDA for market approval. Thorough examination by the DCGI committee members Timeline for approval -12 to 18 months[[Singh, P. M ,2017].

[Audio] If the DCGI review is incomplete because of lacking information, DCGI will give a license for marketing following review. The license was denied by the committee.[Chakraborty, K,2018] The regulatory approval In India is outlined in Figure 1[Singh, P. M ,2017] Figure 1: Drug approval process in India.

[Audio] DRUG APPROVAL PROCESS IN EUROPE In EU drug approval process regulated by EMA . There are two processes involved in the drug approval process in EU :1. Use of Clinical Trials 2. Application for Marketing Authorization.[Patel, R., 2022 ] While marketing authorization applications are authorized at both the member state and centralized levels, clinical trial applications are approved at the member state level.[Singh, P. M.,2017] There are four ways to get a drug's marketing authorization from the European Union..

[Audio] 1. CENTRALIZED PROCEDURE A marketing authorization that is valid across the EU can be obtained by applicants through the centralized procedure as shown in figure 2 [Chakraborty, K. 2019]. Centralized methods are required for: Orphan drugs, medications for HIV/AIDS, diabetes, cancer, and genetic engineering, as well as medications developed from any biotechnology technique.[Vishal, P., 2014] Marketing applications for drugs meant for human use are examined by the Committee for Medicinal Products for Human Use (CHMP)[Navale, S. A., 2023] Timeline: EMA opinion issued within 210 days[Vishal, P., 2014] Figure2: Centralized approval procedure.

[Audio] DECENTRALIZED PROCEDURE Through this process, businesses can concurrently request for authorization in multiple EU countries for products that aren't yet permitted in any of those countries. [.[Patel, R., 2022 ] When a marketing permit is needed, an application is sent to the appropriate authorities in each of the member states. Along with a list of all Concerned Member States (CMSs) and one member state designated as the Reference Member State (RMS), information pertaining to quality, efficacy, safety, and administrative details must be given.[Chakraborty, K. 2019] Time: 210 days. .[Singh, P. M.,2017] The regulatory approval Decentralized procedure In Europe is outlined in Figure 3 [Chakraborty, K. 2019]. Figure 3 : Decentralized approval procedure.

[Audio] MUTUAL RECOGNITION PROCEDURE (MRP) Obtaining marketing authorizations in one or more Member States is the aim of this process. In this case, the applicant requests that one or more CMSs recognize the legitimacy of the RMS's authority. The applicant sends the same dossier, complete with all necessary documents, to each EU member state where authorization is sought.[Patel, R., 2022] Timeline : 390 days.[Navale, S. A., 2023] The regulatory approval Mutual recognition procedure In Europe is outlined in Figure 4 [Navale, S. A., 2023] Figure 4 : Mutual recognition procedure.

[Audio] NATIONAL PROCEDURE A marketing permission can only be obtained in one member state using the nationalized method. An application must be made to the Member State's appropriate authority in order to receive a national marketing license.[Singh, P. M.2017] This process allows for the marketing authorization of new active ingredients that are not required under the Centralized method. Timeline : 210 Days.[Vishal, P.,2014] The regulatory approval National procedure In Europe is outlined in Figure 5.[Navale, S. A., 2023] . Figure 5: National procedure.

[Audio] DRUG APPROVAL PROCESS IN CHINA The State Food and Drug Administration (SFDA) is empowered to approve new medications for marketing under the Drug Administrative Law. The clinical study application and the new drug application are also part of the new drug registration process.[SS, M., 2013] As soon as the drug registration application is received, the Provincial Drug Administration Authorities (PDAAs) should set up the official review of the documents presented, which includes on-site inspection and sampling.[Singh, P. M ,2017].

[Audio] An application must be submitted to the PDAA for market approval. 30 days after SFDA completes a thorough assessment, it is sent to CDE for technical review. Once more, the SFDA received the dossier for regulatory approval. The regulatory clearance Figure 6 depicts the situation in China.[Singh, P. M ,2017] Figure 6 : Drug approval process in china.

[Audio] REFERENCES Botros, S., Botros, M., & Botros, N. (2022). A comparison of the drug approval process in the United States and Canada. International Journal Of Drug Regulatory Affairs, 10(2), 1-8. Zachariah, C. J., & Kamaraj, R. (2020). Regulatory Drug Approval Process in Canada. Research Journal of Pharmacy and Technology, 13(4), 2040-2044. Sandeep, D. S., Raj, K. M., Narayanan, V. A., Dubey, A., & Jose, J. (2019). Regulatory Approval Process for Drugs in Canada-A Challenging Task. Research Journal of Pharmacy and Technology, 12(7), 3206-3210. Singh, P. M., Pahwa, S., Chaudhary, S., & Sethi, V. A. (2017). New drug approval procedure in different countries: a review. International Journal of ChemTech Research, 10(12), 1-21. Chakraborty, K., & Yadav, K. (2018). Drug approval process in US, Europe and India and its regulatory requirements: A Review. International Journal of Drug Regulatory Affairs (IJDRA), 6(3), 31-9..

[Audio] Patel, R., Patel, J., Sharma, S., & Shah, K. (2022). A REVIEW ON DRUG APPROVAL PROCESS FOR US, EUROPE, INDIA, AUSTRALIA, JAPAN. Vishal, P., Rahulgiri, G., Pratik, M., & Kumar, B. J. (2014). A review on drug approval process for US, Europe and India. Int J Drug Regul Aff, 2, 1-11. Navale, S. A., & Basarkar, G. D. (2023). Overview of drug approval process and post approval changes in Europe. International Journal Of Drug Regulatory Affairs, 11(4), 1-15. Chakraborty, K. (2019). A new drug approval process in Europe: A review. International Journal of Drug Regulatory Affairs, 7(3), 21-29. SS, M., Birajdar, S. M., Patil, B. R., & Bhusnure, O. G. (2013). Procedure for drug approval in different countries: a review. Journal of Drug Delivery & Therapeutics, 3(2), 233-238..