Guideline on the regulation of therapeutic products in new. Bioavailability and bioequivalence studies submitted in. Since bioequivalence is the main mechanism used to link the generic product to the innovators original documentation on its safety and efficacy, the following framework is proposed to assist drug regulatory authorities in establishing requirements for. Ema versus usfda regulatory requirements regarding.
Bioequivalence standards must continue to evolve as the landscape of drug development incorporates new levels of complexity. The regulatory requirements of each country vary from each other. The basic regulatory considerations and prospects for conducting. Guideline for bioequivalence studies of generic products december,2006. This document is intended to provide guidance on the conduct of bioequivalence studies for veterinary medicinal products. Bioequivalence studies 101 table 11 list of major guidelines, etc. Regulatory requirements for be nirmal raj marasine jaya pathak 8262015 1regulatory. The present study highlights the relevant regulatory guidelines for the conduct of bioequivalence studies in us, europe, canada, india, south africa and south east asian nations. Introduction this guidance document provides information about how to establish and conduct bioavailability studies for conventional formulations of oral drugs that are used for systemic effects. In determining bioequivalence, for example, between two products such as a commercially available brand product and a potential tobemarketed generic product, pharmacokinetic studies are conducted whereby each of the preparations are administered in a crossover study to volunteer subjects, generally healthy individuals but occasionally in patients. Conducting a bioequivalence study in india introduction. Bioavailability and bioequivalence studies marc sturgill, pharm.
The pertinent situations in which bioequivalence studies are required include. I am proud to see the wealth of outstanding work that has emerged from cder in support of this goal. Test methods 1 design 2 number of subjects 3 selection of subjects 4 drug administration a. Like many regulatory studies, the assessment of bioavailability and bioequivalence can generally be achieved by. Proposal to waive in vivo bioequivalence requirements for who model list of essential medicines immediaterelease, solid oral dosage forms pdf 464kib annex 9.
Introduction n indicate the rationale for the study eg, obtain marketing authorization in. Significance of be studies bioequivalence studies are intended to look at the in vivo execution of a test pharmaceutical item multisource contrasted with a reference pharmaceutical item. Sampling points also vary with respect to the regulatory guidelines of these countries. Understanding regulatory global requirements for nasal drug products julie d. Regulatory intelligence building strategies for drug.
Bioequivalence studies should be conducted according to the principles of good laboratory practice glp andor good clinical practice gcp, as appropriate. Policy on bioequivalence standards for highly variable drug products 20160418 notice. The fda considers two products bioequivalent if the 90% ci of the relative mean cmax, auc 0t and auc 0. Informal communication by the center for drug evaluation and research cder, march 2003 rani s, pargal a. Regulatory agencies world over rely on the data from bioequivalence studies as an important component of granting marketing approval for generic products. Full study reports for pilot studies should be available upon request. Regulatory requirements in bioequivalence high impact list of articles ppts. India makes a long overdue move to ensure better drug safety. It should be read in conjunction with directive 200182ec, as amended. Bioequivalence studies in drug development focuses on the planning, conducting, analysing and reporting of bioequivalence studies, covering all aspects required by regulatory authorities. Study of regulatory requirements for the conduct of. Fda finalized the bioavailability and bioequivalence regulations on january 7, 1977 42 fr 1624, and amended these regulations on april 28, 1992 57 fr 17950. The dynamic role of quality personnel requires alert knowledgeable. Many large pharmaceutical companies have increased their presence in emerging markets in recent years like china markets is predicted to be the second largest market after us in pharmaceuticals.
List of drugs for which be studies have been recently reported. There is a significant amount of guidance on the design and conduct of bioequivalence studies. Additional guidance for organizations performing in vivo bioequivalence studies pdf 371kib. Study on requirements of bioequivalence for registration. The information on this page is current as of april 1 2019. Fdas final rule on requirements for submission of bioequivalence data the be data rule requires an anda applicant to submit data from all be studies the applicant conducts on a drug. Oral immediate release products and entericcoated products i. Bioavailability andor bioequivalence studies play a key role in the drug development period for both new drug products and their generic equivalents. Regulatory requirements in bioequivalence list of high. Regulatory requirements in bioequivalence list of high impact. Guideline for bioequivalence studies of generic products. This master thesis aims to compare the regulatory requirements for bioequivalence studies in the european union and the united states of america that need to be fulfilled in order to successfully submit a generic application according to directive 200183ec 2, article 10. Scientific studies partial bioequivalence new active moiety no no new chemical entity ingredient.
Present status and future requirements sandeep sharma1, ashish baldi2 and rakesh kumar sharma3 1research scholar ik gujral punjab technical university, india 2maharaja ranjit singh punjab technical university, india 3defence food research laboratory, india. A typical outline for a bioequivalence study includes organization of the test and. For both, these studies are also important in the postapproval period in the presence of certain manufacturing changes. Bioavailability and bioequivalance studies and regulatory. Regulatory consideration for generic drug products. Bioavailability and bioequivalance studies and regulatory aspects. Where there is any doubt about the appropriateness of a bioequivalence study, the applicant is strongly advised to seek medsafes advice before submitting the data in support of an nma or cmn. Study report synopses for bioequivalence or comparative bioavailability studies conducted during formulation development should also be included in module 2. As contract research organizations are now familiar with gxps and have become more popular for conducting bioequivalence studies, it is very important that the sponsor has the assurance that the study has been conducted not only to the highest standard of science but also in compliance with regulatory requirements.
It also includes the requirements and registration of generic drugs. Study of regulatory requirements for the conduct of bioequivalence studies in us, europe, canada, india, asean and sadc countries. Bioequivalence studies should be performed for the above products according to the requirements described in the guidelines listed in section 1. Regulatory differences study fda emahc spray pattern x. Pdf an overview on bioequivalence regulatory requirements of. Radiopharmaceuticals regulations on bioavailability and. This article provides the information about important aspect involved in bioequivalence and regulatory requirment for bioequivalence study. This document is intended to provide guidance for the design and. Fda regulations in part 320 21 cfr part 320 establish definitions and requirements for bioavailability and bioequivalence studies. For the most uptodate version of cfr title 21, go to the electronic code of federal regulations ecfr.
Study on requirements of bioequivalence for registration of. Clarification of bioanalytical method validation procedures 20151008 guidance document. Biopharmaceutics classification system based biowaiver 20140529 guidance document. Asean guideline for the conduct of bioequivalence studies the 22nd asean consultative committee for standards and quality pharmaceutical product working group accsqppwg meeting held on 09th th march 2015 in vientiane,lao pdr has endorsed the 4th draft of 1st revision for asean guideline for the conduct of bioequivalence studies. Guidance document conduct and analysis of comparative bioavailability studies date adopted. Study of regulatory requirements for the conduct of bioequivalence. Foodeffect bioavailability and fed bioequivalence studies. Tamboli am, todkar p, zope p, sayyad fj 2010 an overview on bioequivalence. Before going into bioequivalence studies it is essential for the pharmaceutical industry to study the guidelines of bioequivalence for the respective country where the industry wants to market. Pdf study of regulatory requirements for the conduct of. Therefore, the regulatory teams within manufacturers. Although there are a few exceptions, generally a bioequivalent comparison of test to reference. Most of the international regulatory authorities and.
Requirements for registration of pharmaceuticals for human use 88. In bioequivalence studies, the plasma concentration time curve is generally to assess the rate and extent of. Russian regulatory system has unique features like obligatory clinical studies incorporated to a pharmaceutical registration procedure, extensive preclinical studies program for registration and full quality control of first imported batches after registration. Conduct and analysis of comparative bioavailability studies 20180608. Pharmaceutical administration and regulations in japan. Currently there is no single publicly available repository that comprehensively captures the registration and cmc requirements of lmics. Regulatory dose india makes a long overdue move to ensure better drug safety the health ministry has made bioequivalence studies compulsory for some generic drugs. This study covers the introduction to generic drugs, in china regulatory authorities. Submission of summary bioequivalence data for abbreviated. Builtin quality systems in regulated contract research. General requirements all bioequivalence studies must be conducted in a manner that assures th e reliability of the data generated. Guideline on the conduct of bioequivalence studies for.
Guideline for bioequivalence studies of generic products index section 1. The three be approaches that are currently consistently required are 1 be studies with clinical endpoints for most topical drug products. The regulatory expectations and norms for proving bioequivalence as a marker for therapeutic equivalence are generally standardised with some country specific regulations or requirements that may differ. Guidance on bioequivalence studies for reproductive health. A comparative study of the differences in study design and specifications have also been addressed. Applicants should also refer to other relevant european and vich guidelines, including those. Table 1 from study of regulatory requirements for the. Bioequivalence study will be carried out in healthy volunteer unless drug carried safety issue it will carry out in patientus fda general consideration babe, 2003. Understanding regulatory global requirements for nasal. Radiopharmaceuticals regulations on bioavailability and bioequivalence. Bioequivalence means the absence of a significant difference in the rate and extent to which the. Cmc issues can be even more challenging in lmics due to the lack of awareness of all the regulatory requirements.
1081 107 85 1538 1562 657 702 485 567 971 1414 1266 230 497 835 1529 1497 343 634 1627 1348 1242 972 410 957 1266 34 545 1209 73 849 696 1238