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ICH is based on biological agents

ICH is based on biological agents

  • Categories:Company news
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  • Time of issue:2020-03-05 10:37
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ICH is based on biological agents

(Summary description)Whether generic drugs can apply for bioequivalence test exemption has always been a matter of great concern in the industry. In October 2016, the concept paper and drafting plan of bioequivalence test exemption guidelines based on biopharmaceutical classification system. The guidelines are currently in the first stage of the development process (step 1).
The document is included in the comprehensive discipline series. The purpose is to provide guiding suggestions for the exemption of bioequivalence test of drugs classified according to the biopharmaceutical classification system.
1. Reasons and necessity of drafting
Based on BCS classification, bcs1 and bcs3 drugs can be exempted from bioequivalence test. Prior to this, the European Union, the United States, Canada and who have issued the draft guiding principles / guidelines on the feasibility of drug bioequivalence test exemption based on BCS. The relevant principles of Japan also include the possibility of exemption from drug bioequivalence test based on changes in formulation (see Table 1). However, the BCS based drug bioequivalence test exemption has not yet reached a global consensus, mainly because there are differences in the supporting data requirements for applying for exemption in these guidelines, and even if the scientific data used to support the BCS based bioequivalence test exemption in different countries or regions are the same, there are still differences in the understanding of these data. In addition, there are differences in the theory of biopharmaceutical classification system in different countries or organizations, which makes pharmaceutical companies need to follow different technical requirements when applying for drug marketing license in different countries and regions. In view of the above problems, it is expected that these problems can be solved by coordinating the formulation of a general consensus and exemption requirements for bioequivalence test exemption based on BCS.
2. Problems to be solved
2.1. Description of relevant characteristic indexes of drugs based on BCS classification system
Solubility: to judge whether a drug has high solubility or low solubility, it should be defined according to the maximum therapeutic dose or the maximum dose specification on the specific drug label.
Permeability: at present, there are differences in measurement methods, whether they are based on in vitro data, in vivo data, or both, and they need to be coordinated; If the applicable method is determined, it shall also clearly judge whether the drug is high permeability or low permeability.
2.2. Consideration of supporting data on bioequivalence test exemption
Threshold criteria for dissolution studies need to be established to determine whether the drug is BCS class 1 or class 3 (please note that the bioequivalence test exemption for BCS class 1 and class 3 drugs is applicable and acceptable).
It is necessary to formulate the requirements for the comparison between the test drug and the reference drug or the prescription of the reference drug, and what are the key excipients affecting the drug absorption rate and degree. Formulate the standards for quantitative comparison of prescriptions and provide data to prove that excipients are non key factors.
The in vitro dissolution test data need to clearly establish the dissolution test conditions. It also needs to be clear whether it is feasible to adopt standards different from the determined conditions, such as the variation range of mixing speed. If it can be adopted, what instructions need to be provided.
It should be clear whether the bioequivalence test exemption based on BCS is only applicable to pharmaceutically equivalent products. In addition, when multiple specifications are listed in the reference preparation or reference prescription, for example, 10mg and 20mg rapid release tablets.
It should also be clear whether each specification of BCS based bioequivalence test exemption needs to be matched one by one, whether 10mg reference preparation / reference article is compared with 10mg test sample, 20mg reference preparation / reference article is compared with 20mg test sample, or whether after a comprehensive BCS based bioequivalence test exemption is conducted for one specification, other specifications can be exempted according to this result.
3. Significance of drafting guiding principles
After the formal introduction of BCS based bioequivalence test exemption guidelines, some in vivo studies used to prove the bioequivalence of drugs may be exempted, which reduces the number of healthy subjects to be exposed to drugs and reduces the cost and time of drug research and development. By accepting the same test methods adopted by pharmaceutical enterprises in different regulatory regions, member states have accelerated the speed of drug approval. In addition, the principle can also be used for reference by the regulatory authorities of developing countries that are not members of IC

  • Categories:Company news
  • Author:
  • Origin:
  • Time of issue:2020-03-05 10:37
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Information

Whether generic drugs can apply for bioequivalence test exemption has always been a matter of great concern in the industry. In October 2016, the concept paper and drafting plan of bioequivalence test exemption guidelines based on biopharmaceutical classification system. The guidelines are currently in the first stage of the development process (step 1).
The document is included in the comprehensive discipline series. The purpose is to provide guiding suggestions for the exemption of bioequivalence test of drugs classified according to the biopharmaceutical classification system.
1. Reasons and necessity of drafting
Based on BCS classification, bcs1 and bcs3 drugs can be exempted from bioequivalence test. Prior to this, the European Union, the United States, Canada and who have issued the draft guiding principles / guidelines on the feasibility of drug bioequivalence test exemption based on BCS. The relevant principles of Japan also include the possibility of exemption from drug bioequivalence test based on changes in formulation (see Table 1). However, the BCS based drug bioequivalence test exemption has not yet reached a global consensus, mainly because there are differences in the supporting data requirements for applying for exemption in these guidelines, and even if the scientific data used to support the BCS based bioequivalence test exemption in different countries or regions are the same, there are still differences in the understanding of these data. In addition, there are differences in the theory of biopharmaceutical classification system in different countries or organizations, which makes pharmaceutical companies need to follow different technical requirements when applying for drug marketing license in different countries and regions. In view of the above problems, it is expected that these problems can be solved by coordinating the formulation of a general consensus and exemption requirements for bioequivalence test exemption based on BCS.
2. Problems to be solved
2.1. Description of relevant characteristic indexes of drugs based on BCS classification system
Solubility: to judge whether a drug has high solubility or low solubility, it should be defined according to the maximum therapeutic dose or the maximum dose specification on the specific drug label.
Permeability: at present, there are differences in measurement methods, whether they are based on in vitro data, in vivo data, or both, and they need to be coordinated; If the applicable method is determined, it shall also clearly judge whether the drug is high permeability or low permeability.
2.2. Consideration of supporting data on bioequivalence test exemption
Threshold criteria for dissolution studies need to be established to determine whether the drug is BCS class 1 or class 3 (please note that the bioequivalence test exemption for BCS class 1 and class 3 drugs is applicable and acceptable).
It is necessary to formulate the requirements for the comparison between the test drug and the reference drug or the prescription of the reference drug, and what are the key excipients affecting the drug absorption rate and degree. Formulate the standards for quantitative comparison of prescriptions and provide data to prove that excipients are non key factors.
The in vitro dissolution test data need to clearly establish the dissolution test conditions. It also needs to be clear whether it is feasible to adopt standards different from the determined conditions, such as the variation range of mixing speed. If it can be adopted, what instructions need to be provided.
It should be clear whether the bioequivalence test exemption based on BCS is only applicable to pharmaceutically equivalent products. In addition, when multiple specifications are listed in the reference preparation or reference prescription, for example, 10mg and 20mg rapid release tablets.
It should also be clear whether each specification of BCS based bioequivalence test exemption needs to be matched one by one, whether 10mg reference preparation / reference article is compared with 10mg test sample, 20mg reference preparation / reference article is compared with 20mg test sample, or whether after a comprehensive BCS based bioequivalence test exemption is conducted for one specification, other specifications can be exempted according to this result.
3. Significance of drafting guiding principles
After the formal introduction of BCS based bioequivalence test exemption guidelines, some in vivo studies used to prove the bioequivalence of drugs may be exempted, which reduces the number of healthy subjects to be exposed to drugs and reduces the cost and time of drug research and development. By accepting the same test methods adopted by pharmaceutical enterprises in different regulatory regions, member states have accelerated the speed of drug approval. In addition, the principle can also be used for reference by the regulatory authorities of developing countries that are not members of ICH.

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