Regulatory requirements for the registration of generic medicines and format of drug dossiers: procedures in Sri Lanka in comparison with selected regulatory authorities

Figures & data

Table 1 Bioequivalence data requirements and biowaiver data acceptance by the selected RAs

Table 2 Drug approval timelines of the selected NMRAs

Health Canada. Guidance document: biopharmaceutics classification system based biowaiver. Ottawa: Health Products and Food Branch, Health Canada; 2014. p. 12.

 Google Scholar

The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use. Note for guidance on the investigation of bioavailability and bioequivalence. 2001. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003008.pdf. Accessed 10 Oct 2016.

 Google Scholar

Central Drugs Standard Control Organization India. Guidance for industry on preparation of common technical document for import/manufacture and marketing approval. New Delhi: Ministry of Health & Family Welfare Govt. of India; 2010. p. 110.

 Google Scholar

Ministry of Health Malaysia. Guidance on Biopharmaceutics Classification System (BCS) based biowaiver. Malaysia: Ministry of Health Malaysia; 2013.

 Google Scholar

National Pharmaceutical Bureau Ministry of Health Malaysia. Generic products containing drug substances/active pharmaceutical ingredients (api) that may be considered for biowaiver. 2014. http://npra.moh.gov.my/images/Guidelines_Central/Guidelines_on_Bioequivalence_BE/Guidance-on-BCS-Based-Biowaiver.pdf. Accessed 7 June 2016.

 Google Scholar

Health Sciences Authority Singapore. Guidance on medicinal product registration in Singapore. 2011. http://www.hsa.gov.sg/content/hsa/en.html. Accessed 1 June 2015.

 Google Scholar

United States Food and Drug Administration. Guidance for industry: waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. Rockville, USA; 2015.

 Google Scholar

United States Food and Drug Administration. Guidance for industry- waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. 2000. https://www.fda.gov/downloads/Drugs/Guidances/ucm070246.pdf. Accessed 20 Sept 2016.

 Google Scholar

United States Food and Drug Administration. CFR-code of Federal Regulations-Bioavailability and bioequivalence requirements. 2013. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=320&showFR=1&subpartNode=21:5.0.1.1.7.2. Accesed 20 Sept 2016.

 Google Scholar

Melchior R. How transparent are regulatory agencies with regard to review timelines? A global review. Chicago: Thomson Reuters France; 2011.

 Google Scholar

Anand K, Mallu UR, Kuraku M, et al. Pharmaceutical drug products approval procedure in Australia. Exp. 2013;11(3):690-705.

 Google Scholar

Health Canada. Guidance for industry-Management of Drug Submissions. In: Therapeutic products directorate. Ontario: Minister of Public Works and Government Services Canada; 2013. p. 46.

 Google Scholar

Agency EM. The centralised procedure at the EMA. Secondary the centralised procedure at the EMA. 2016. http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2016/02/WC500201043.pdf.

 Google Scholar

Pacific Bridge Medical. Pharmaceutical and API product registration in the other Asian countries. 2016. http://www.pacificbridgemedical.com/regulatory-services/pharmaceutical/product-registration/others/. Accessed 5 Dec 2016.

 Google Scholar

Central Drugs Standards Control Organization, India. CDSCO Timelines. 2014. http://www.cdsco.nic.in//writereaddata/upTimeline%20CDSCO.pdf.

 Google Scholar

National Pharmaceutical Control Bureau Malaysia, Drug registration guidance document. First ed. Selangor Darul Ehsan, Malaysia National Pharmaceutical Control Bureau Ministry of Health, Malaysia. 2014. https://www.pmda.go.jp/files/000204339.pdf. Accessed 15 Dec 2016.

 Google Scholar

Health Sciences Authority in Singapore. Guidance on medicinal product registration in Singapore. 2011. http://www.hsa.gov.sg/content/dam/HSA/HPRG/Western_Medicine/Overview_Framework_Policies/Guidelines_on_Drug_Registration/Updates%20for%20Guidance%20on%20Medicinal%20Product%20Regist. Accessed 15 June 2016.

 Google Scholar

Ministry of Food and Drug Safety Republic of Korea. Guide to drug approval system in Korea. 2017. http://www.masung.co.kr/bbs/board.php?bo_table=s03_01_eng&wr_id=1. Accessed 10 June 2017.

 Google Scholar