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JAPAN: ORGANISATION OF PMDA, PHARMACEUTICAL LAWS & REGULATIONS, TYPES OF REGISTRATION APPLICATION

The document presents an overview of the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, highlighting its role in regulating drugs and medical devices alongside the Ministry of Health, Labor, and Welfare. It details various pharmaceutical laws and regulations governing the approval and monitoring of pharmaceuticals, such as the Pharmaceutical and Medical Device Act, and outlines the types of registration applications required for market entry, including those for New Drugs, Abbreviated New Drugs, and Biologics. Additionally, the document emphasizes the importance of safety, efficacy, and quality in the regulatory processes to protect public health.

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JAPAN: ORGANISATION OF PMDA, PHARMACEUTICAL LAWS & REGULATIONS, TYPES OF REGISTRATION APPLICATION PARUL INSTITUTE OF PHARMACY PRESENTED BY: Anjali Yadav 2nd Sem M.PHARM Regulatory Affairs 1 Anjali Yadav
CONTENT Introduction Organisation of PMDA Pharmaceutical Laws and Regulations Types of Registration Application References 2 Anjali Yadav
INTRODUCTION PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of health and labour welfare (MHLW). The PMDA was established in April 2004 in order to serve in areas of review of drugs and medical devices, post – marketing safety measures, relief services for adverse health effects. There obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices. The role of the PMDA is to provide concerning the clinical trials of new drugs and medical devices, and to conduct approval reviews and surveys of the reliability of application data. 3 Anjali Yadav
FUNCTIONS • Drug and medical device testing • Scientific review of market authorization applications based on Japanese Pharmaceutical law • Advice in clinical trials or in the preparation of dossiers for the registration procedure (NDA) • Inspection and Conformity assessment of Good Clinical Practice (GCP), Good Laboratory Practice (GLP) & Good Practice Systems and programs (GPSP) • Auditing of manufacturers to ensure they conform to Good Manufacturing Practice (GMP) and have a suitable Quality Management System (QMS). 4 Anjali Yadav
PMDA TRIANGLE SYSTEM REVIEW RELIEF SAFETY SAFETY TRIANGLE SYSTEM PMDA focuses on 3 key services which is a Safety Triangle System. 5 Anjali Yadav
PHARMACEUTICAL LAWS AND REGULATIONS Pharmaceutical administration in Japan is based on various laws and regulations, consisting mainly of: • Pharmaceutical and Medical Device Act • Law Concerning the Establishment for Pharmaceuticals and Medical Devices Organization • Law Concerning Securing Stable Supply of Blood Products • Poisonous and Deleterious Substances Control Law • Narcotics and Psychotropics Control Law • Cannabis Control Law • Opium Law • Stimulants Control Law 6 Anjali Yadav
PHARMACEUTICAL LAWS AND REGULATIONS 7 1. Pharmaceutical and Medical Device Act The Pharmaceutical and Medical Device Act are to improve public health through regulations required to assure quality, efficacy, and safety of drugs, quasi-drugs, cosmetics, medical devices, and regenerative medicine products and to prevent hazard and expansion of hazard in public health caused by use of those products, as well as through measures required to promote R&D of drugs, medical devices and regenerative medicine products. Anjali Yadav
PHARMACEUTICAL LAWS AND REGULATIONS 8 2. Law Concerning the Establishment for Pharmaceuticals and Medical Devices Organization This law establishes the Pharmaceuticals and Medical Devices Agency (PMDA), which is responsible for the evaluation and approval of pharmaceuticals and medical devices in Japan. The PMDA conducts reviews of new drug applications, monitors post-market safety, and enforces regulatory compliance to protect public health. Anjali Yadav
PHARMACEUTICAL LAWS AND REGULATIONS 9 3. Law Concerning Securing Stable Supply of Blood Products This law governs the collection, processing, storage, and distribution of blood and blood products in Japan. It aims to ensure the safety and availability of blood products for medical use while safeguarding the health of blood donors and recipients. Anjali Yadav
PHARMACEUTICAL LAWS AND REGULATIONS 10 4. Poisonous and Deleterious Substances Control Law This law regulates the handling, storage, transportation, and disposal of poisonous and deleterious substances in Japan. It establishes controls to prevent misuse, accidents, and environmental contamination associated with these substances, which include hazardous chemicals, pesticides, and industrial materials. Anjali Yadav
PHARMACEUTICAL LAWS AND REGULATIONS 11 5. Narcotics and Psychotropics Control Law This law regulates the production, import, export, distribution, and prescription of narcotics and psychotropic substances in Japan. It aims to prevent drug abuse, trafficking, and diversion while ensuring access to controlled substances for legitimate medical purposes under strict supervision and regulation. Anjali Yadav
PHARMACEUTICAL LAWS AND REGULATIONS 12 6. Cannabis Control Law: This law prohibits the cultivation, possession, sale, and use of cannabis (marijuana) in Japan. It imposes penalties for violations and establishes controls to prevent the misuse and diversion of cannabis, which is classified as a controlled substance with no recognized medical use under Japanese law. Anjali Yadav
PHARMACEUTICAL LAWS AND REGULATIONS 13 7. Opium Law: Similar to the Narcotics and Psychotropics Control Law, the Opium Law regulates the production, import, export, distribution, and prescription of opium and its derivatives in Japan. It aims to prevent opium abuse and diversion while allowing for medical use under strict regulation and supervision. Anjali Yadav
PHARMACEUTICAL LAWS AND REGULATIONS 14 8. Stimulants Control Law: This law regulates the production, import, export, distribution, and prescription of stimulant drugs, such as amphetamines and methamphetamines, in Japan. It aims to prevent stimulant abuse, trafficking, and diversion while ensuring access to these drugs for legitimate medical purposes under strict supervision and regulation. Anjali Yadav
TYPES OF REGISTRATION APPLICATION Japan has a well-established regulatory framework governing the approval and marketing of pharmaceutical products. The Pharmaceuticals and Medical Devices Agency (PMDA), along with the Ministry of Health, Labor, and Welfare (MHLW), oversees the registration process for pharmaceuticals. Various types of registration applications are required depending on the stage of drug development and intended use. 15 Anjali Yadav
TYPES OF REGISTRATION APPLICATION Investigational New Drug New Drug Application Abbreviated New Drug Application Biologic License Application (BLA) Orphan Drug Medical Device 16 Anjali Yadav
INVESTIGATIONAL NEW DRUG • The Japanese regulatory authority follows the Common Technical Document (CTD) drug application format and hence the applicant should prepare the Investigational New Drug (IND) application and documents as per the CTD format. • For drugs that are still in the testing Phase. • The primary objective of the IND application is to obtain approval from the regulatory authorities to conduct clinical trials with investigational drugs in Japan. This application serves to ensure the safety and efficacy of the drug candidates before they are administered to human subject. 17 Anjali Yadav
COMPONENTS OF INVESTIGATIONAL NEW DRUG APPLICATION 1. Chemical and Pharmaceutical Information 2. Nonclinical data 3. Clinical study Protocol 4. Investigator’s Brochure 18 Anjali Yadav
COMPONENTS OF INVESTIGATIONAL NEW DRUG APPLICATION 1. Chemical and Pharmaceutical Information: Detailed information regarding the chemical composition of the investigational drug, its manufacturing process, and its pharmaceutical form is provided in the application. 2. Nonclinical Data: Preclinical studies play a crucial role in evaluating the safety profile of the investigational drug. This section of the application includes data from pharmacology, toxicology, and pharmacokinetics studies conducted in laboratory settings. 19 Anjali Yadav
COMPONENTS OF INVESTIGATIONAL NEW DRUG APPLICATION 3. Clinical Study Protocol: A well-defined clinical study protocol outlines the objectives, study design, dosing regimen, and safety monitoring procedures for the proposed clinical trials. It also includes information on patient eligibility criteria and study endpoints. 4. Investigator's Brochure: This document provides comprehensive information about the investigational drug, including its pharmacological properties, pharmacokinetics, and safety profile. It serves as a reference for investigators conducting clinical trials. 20 Anjali Yadav
INVESTIGATIONAL NEW DRUG APPROVAL PROCESS 21 Anjali Yadav
Basic Investigation Screening Tests Study of Manufacturing techniques/Formulations and Pharmaceutical Research Phytochemistry, Toxicity on GLP, Pharmacology & Pharmacokinetics Evaluation of Non – Clinical Studies INVESTIGATIONAL NEW DRUG APPROVAL PROCESS 22 Anjali Yadav
Clinical Trial Notification to PMDA Receipt of Notification Review of Notification Guidance on Investigation Required INVESTIGATIONAL NEW DRUG APPROVAL PROCESS 23 Anjali Yadav
NEW DRUG APPLICATION • A New Drug Application (NDA) is a pivotal document submitted by a pharmaceutical company to regulatory authorities, such as the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, seeking approval to market and distribute a new pharmaceutical product. • This comprehensive application serves as the primary vehicle through which the company communicates essential information about the new drug to the regulatory agency, demonstrating its safety, efficacy, and quality for the intended therapeutic use. 24 Anjali Yadav
COMPONENTS OF NEW DRUG APPLICATION 1. Chemistry, Manufacturing, and Controls (CMC) Information 2. Nonclinical Pharmacology and Toxicology Studies 3. Clinical Data 4. Drug Labelling and Prescribing Information 5. Risk Management Plan (RMP) 6. Regulatory Commitments 25 Anjali Yadav
COMPONENTS OF NEW DRUG APPLICATION 1. Chemistry, Manufacturing, and Controls (CMC) Information: This section provides detailed data on the composition, manufacturing process, and quality control measures of the new drug. It encompasses information on the drug substance, drug product formulation, manufacturing facilities, and analytical methods used to assess product quality and stability. 26 Anjali Yadav
COMPONENTS OF NEW DRUG APPLICATION 2. Nonclinical Pharmacology and Toxicology Studies: Preclinical data from pharmacological and toxicological studies conducted in laboratory animals are included to assess the drug's pharmacological activity, potential toxicity, and safety profile. These studies provide crucial insights into the drug's mechanism of action, potential side effects, and dose-response relationships. 27 Anjali Yadav
COMPONENTS OF NEW DRUG APPLICATION 3. Clinical Data: The cornerstone of the NDA is the clinical data obtained from human trials conducted during the drug development process. These studies are designed to evaluate the drug's safety and efficacy in patients with the target disease or condition. The NDA includes detailed summaries of clinical trial protocols, results, and analyses, along with safety monitoring data and adverse event reports. 28 Anjali Yadav
COMPONENTS OF NEW DRUG APPLICATION 4. Drug Labelling and Prescribing Information: The proposed labelling for the new drug, including package inserts, prescribing information, and patient information leaflets, is provided in the NDA. This information outlines essential details such as indications, dosage and administration instructions, contraindications, warnings, precautions, and potential adverse reactions associated with the use of the drug. 29 Anjali Yadav
COMPONENTS OF NEW DRUG APPLICATION 5. Risk Management Plan (RMP): In some cases, especially for drugs with complex safety profiles or significant risks, the NDA may include a risk management plan aimed at minimizing and managing potential risks associated with the drug's use. The RMP outlines specific pharmacovigilance activities, risk minimization strategies, and post-marketing surveillance plans to ensure ongoing evaluation of the drug's safety profile. 30 Anjali Yadav
COMPONENTS OF NEW DRUG APPLICATION 6. Regulatory Commitments: The NDA may also include commitments from the pharmaceutical company to conduct additional post-approval studies, implement risk mitigation measures, or provide further data to address specific regulatory concerns raised during the review process 31 Anjali Yadav
NEW DRUG APPLICATION APPROVAL PROCES 32 Anjali Yadav
Application PMDA Approval Review MHLW Evaluation & Licensing Compliance Review GMP Review Pharmaceutical Affairs and Food Sanitation Council Experts Evaluation Committees Pharmaceutical Affairs Section Consultation Enquiry Response Minister of MHLW (Final Evaluation) Approval NEW DRUG APPLICATION APPROVAL PROCESS 33 Anjali Yadav
ABBREVIATED NEW DRUG APPLICATION • In Japan, the PMDA reviews generic drug applications, and this includes the assessment of bioequivalence studies. This bioequivalence assessment helps to confirm the quality, efficacy, and safety of the product based on documents submitted by applicants. • In Japan, the drug product is considered to be a generic drug, if it covers the following criteria: • It contains an API (Active Pharmaceutical Ingredient), • If the API has a different hydrate form or crystalline form from the original drug, and • If the API has the same chemical structure as the original drug 34 Anjali Yadav
COMPONENTS OF ABBREVIATED NEW DRUG APPLICATION 1. Product Development 2. Bioequivalence studies 3. Quality Control and Manufacturing 4. Regulatory submission 5. Review Process 35 Anjali Yadav
COMPONENTS OF ABBREVIATED NEW DRUG APPLICATION 1. Product Development: Generic drug manufacturers in Japan begin the development process by identifying a reference product, usually a branded drug that has already been approved and marketed. They then work to replicate the active pharmaceutical ingredients (APIs) and formulation of the reference product. 36 Anjali Yadav
COMPONENTS OF ABBREVIATED NEW DRUG APPLICATION 2. Bioequivalence Studies: Similar to the requirements in the United States, demonstrating bioequivalence is a critical aspect process in Japan. Bioequivalence studies compare the pharmacokinetic parameters of the generic product with those of the reference product to ensure that they are equivalent in terms of rate and extent of absorption. 37 Anjali Yadav
COMPONENTS OF ABBREVIATED NEW DRUG APPLICATION 3. Quality Control and Manufacturing: The generic drug manufacturer must adhere to strict quality control standards and Good Manufacturing Practice (GMP) regulations throughout the manufacturing process to ensure the consistency and quality of the finished product. 38 Anjali Yadav
COMPONENTS OF ABBREVIATED NEW DRUG APPLICATION 4. Regulatory Submission: Once the generic drug has been developed and bioequivalence has been demonstrated through studies, the manufacturer submits a Generic Drug Application to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. This application includes comprehensive data on the product's formulation, manufacturing process, bioequivalence studies, stability data, and other relevant information. 39 Anjali Yadav
COMPONENTS OF ABBREVIATED NEW DRUG APPLICATION 5. Review Process: The PMDA conducts a thorough review of the Generic Drug Application to assess the quality, safety, and efficacy of the generic product. This review process involves evaluating the submitted data against regulatory standards and requirements to determine whether the generic drug meets the necessary criteria for approval. 40 Anjali Yadav
ABBREVIATED NEW DRUG APPLICATION APPROVAL PROCESS 41 Anjali Yadav
Applicant Application Incorporate Administrative Agency PMDA (Pharmaceutical & Medical Device Agency) Outcome of Inspection MHLW GCP/ GLP/GMP Audit & Compliance Foreign Site Manufacturing Plant Prefectural Government Domestic Site GMP Inspection Outcome of Review APPROVAL ABBREVIATED NEW DRUG APPLICATION APPROVAL PROCESS 42 Anjali Yadav
BIOLOGICS LICENSE APPLICATION • The PMDA’s office of biologicals provides consultations concerning clinical trials of new biologic drugs and handles biotechnology medicines, which includes biosimilars. • Requirements for biologic drugs differ from general drugs and depend on whether a biological product is a regenerative medicine product or not. • The MHLW designates a product as a biological drug after its consultation with the Pharmaceutical Affairs and Food Sanitation Council (PAFSC). 43 Anjali Yadav
BIOLOGICS LICENSE APPLICATION • Biosimilar drugs: • Biosimilar drugs are considered as those drugs that are “equivalent and homogenous to the reference biological product in terms of efficacy, quality, and safety.” • In Japan, the approval of biosimilar products tends to reduce the amount of new information required and the timeline for approval. • The applicant can reduce the burden in case if it has information gathered for its foreign license or approval. 44 Anjali Yadav
COMPONENTS OF BIOLOGICS LICENSE APPLICATION 1. Product Development 2. Clinical Trials 3. Quality Control and Manufacturing 4. Comparative Studies 5. Post-Marketing Commitments 6. Labelling and Packaging 7. Risk Management Plan (RMP) 45 Anjali Yadav
COMPONENTS OF BIOLOGICS LICENSE APPLICATION 1. Product Development: Biologics are complex therapeutic products derived from living organisms or their components, such as proteins, nucleic acids, or cells. Product development involves extensive research and development to characterize the biologic, establish manufacturing processes, and conduct preclinical studies to assess safety and efficacy. 46 Anjali Yadav
COMPONENTS OF BIOLOGICS LICENSE APPLICATION 2. Clinical Trials: Clinical development for biologics typically involves conducting clinical trials to evaluate safety and efficacy in patients with the target disease or condition. These trials are designed to generate robust data on the biologic's therapeutic effects, dosing regimens, and safety profile. 47 Anjali Yadav
COMPONENTS OF BIOLOGICS LICENSE APPLICATION 3. Quality Control and Manufacturing: Ensuring the quality and consistency of biologic products is essential. Manufacturers must adhere to strict quality control standards and Good Manufacturing Practice (GMP) regulations throughout the manufacturing process to produce biologics that meet regulatory requirements. 48 Anjali Yadav
COMPONENTS OF BIOLOGICS LICENSE APPLICATION 4. Comparative Studies: In addition to demonstrating the safety and efficacy of the biologic product, comparative studies may be required to establish similarity or comparability to a reference product, especially if the biologic is a biosimilar or interchangeable product. These studies assess similarities in quality attributes, pharmacokinetics, pharmacodynamics, and immunogenicity between the biologic and the reference product. 49 Anjali Yadav
COMPONENTS OF BIOLOGICS LICENSE APPLICATION 5. Post-Marketing Commitments: Regulatory authorities may request post-marketing commitments as a condition for approval, particularly for novel or complex biologics. These commitments may include additional safety monitoring, pharmacovigilance studies, real-world evidence generation, or further clinical trials to address specific concerns or uncertainties identified during the review process. 50 Anjali Yadav
COMPONENTS OF BIOLOGICS LICENSE APPLICATION 6. Labelling and Packaging: The BLA submission includes proposed labeling and packaging information for the biologic product. This includes prescribing information, dosage instructions, contraindications, warnings, precautions, adverse reaction information, and other essential details intended for healthcare professionals and patients. 51 Anjali Yadav
COMPONENTS OF BIOLOGICS LICENSE APPLICATION 7. Risk Management Plan (RMP): A comprehensive risk management plan may be required, particularly for biologics with complex safety profiles or unique risks. The RMP outlines strategies and measures to identify, minimize, and manage risks associated with the use of the biologic product throughout its lifecycle, including post-marketing surveillance and risk mitigation activities. 52 Anjali Yadav
BIOLOGICS LICENSE APPLICATION APPROVAL PROCESS 53 Anjali Yadav
Applicant Fulfil all requirements for Biosimilars Application Ministry of Health and Labour Welfare (MHLW) PMDA Review and Manufacturing Inspection BIOLOGICS LICENSE APPLICATION APPROVAL PROCESS 54 Anjali Yadav
Schedule Meeting with Applicant Complete detailed review report MHLW’s Pharmaceutical & Food Safety Bureau Forward Report MHLW’s Review APPROVE BIOLOGICS LICENSE APPLICATION APPROVAL PROCESS 55 Anjali Yadav
ORPHAN DRUG • Japan defines a disease as rare if fewer than 50,000 people are affected. Pharmaceutical companies can request orphan drug designation to treat such rare diseases. • Criteria for drugs to obtain orphan drug designation • The medical need is very high. • The intended use is for severe diseases • In addition, the drug needs to meet the following conditions • No other drug or medical treatment is available for the disease. • The product under review exhibits significantly high efficacy and safety compared with existing products. • There exists a strong rationale for the use of the product. 56 Anjali Yadav
COMPONENTS OF ORPHAN DRUG APPLICATION 1. Orphan Drug Designation 2. Clinical Development 3. Priority Review and Approval 4. Post-Marketing Commitments 57 Anjali Yadav
COMPONENTS OF ORPHAN DRUG APPLICATION 1. Orphan Drug Designation: Before submitting an application for approval, the drug must first receive orphan designation from the PMDA. This designation is granted to drugs intended for the treatment, diagnosis, or prevention of rare diseases that affect a small number of patients in Japan. The criteria for orphan designation are outlined in the "Orphan Drug Designation System" provided by the PMDA. 58 Anjali Yadav
COMPONENTS OF ORPHAN DRUG APPLICATION 2. Clinical Development: Similar to the development of non- orphan drugs, clinical studies are conducted to evaluate the safety and efficacy of the orphan drug. However, given the challenges of conducting clinical trials for rare diseases with limited patient populations, the PMDA may accept smaller or less conventional trial designs, such as single-arm studies or studies with surrogate endpoints. 59 Anjali Yadav
COMPONENTS OF ORPHAN DRUG APPLICATION 3. Priority Review and Approval: Orphan drugs may be eligible for priority review by the PMDA, which expedites the review process to accelerate access to treatment for patients with rare diseases. The PMDA evaluates the orphan drug application based on its scientific merit, clinical data, and the unmet medical need for patients with the rare disease. 60 Anjali Yadav
COMPONENTS OF ORPHAN DRUG APPLICATION 4. Post-Marketing Commitments: As a condition for approval, the PMDA may request post-marketing commitments, such as additional safety monitoring or long-term efficacy studies, to further evaluate the orphan drug's benefit-risk profile in real- world clinical practice. 61 Anjali Yadav
MEDICAL DEVICE • Registration of Medical devices and pharmaceuticals in Japan is complicated, and high costs and long timeframes. • In some cases, Japanese regulators require clinical trials in Japan to be conducted. • Product registration in Japan needs to be pursued carefully and only after determining that there is a strong market demand for your product. • In order to market medical devices in Japan, a foreign manufacturer has to obtain approval/certification or submit notification. 62 Anjali Yadav
Class – 1 Class – 2 Class – 3 Class – 4 General Medical Device Controlled Medical Device Specially Controlled Medical Device Specially Controlled Medical Device Extremely Low Risk Low Risk Medium Risk High Risk 63 Anjali Yadav
Nebulizers, X- ray film X- ray imaging device, injection needle, Ultrasonic diagnostic device Artificial dialyzer, Infusion Pump, Artificial Bone Pacemaker, Coronary stent, Artificial Blood vessel Self Declaration Third Party Certification Ministers Approval Third Party Certification Ministers Approval 64 Anjali Yadav
REGISTRATION PROCEDURE FOR MEDICAL DEVICES The registration pathway for your device is determined by its classification and associated Japan Medical Device Nomenclature (JMDN). To market medical devices in Japan, your Marketing Authorization Holder (MAH) must register your device through one of the following procedures. 65 Anjali Yadav
REGISTRATION PROCEDURE FOR MEDICAL DEVICE Premarket Notification (Todoke) Pre-market certification (Ninsho) Pre-market approval (Shonin) 66 Anjali Yadav
REGISTRATION PROCEDURE FOR MEDICAL DEVICE 1. Premarket Notification (Todoke) To register General Medical Devices (Class I), you must file a pre-market submission to the PMDA. There is No review/assessment by the PMDA will be conducted. 67 Anjali Yadav
REGISTRATION PROCEDURE FOR MEDICAL DEVICE 2. Premarket Certification (Ninsho) Class II (and a limited number of Class III) devices which have an associated certification standard (JIS), are subject to pre- market certification. Many, but not all, Japan Industrial Standards are based on existing ISO/IEC standards. MAH will file the application with a Registered Certification Body (RCB). The process is similar to the European CE marking process where reviews are outsourced to a third party similar to a Notified Body. 68 Anjali Yadav
REGISTRATION PROCEDURE FOR MEDICAL DEVICE 3. Premarket Approval (Shonin) Class II and III devices without a specific certification standard are subject to the pre-market approval process. This also applies to all Class IV devices. In this case your MAH will file a pre-market approval application with the PMDA and ultimately obtain approval from the MHLW. 69 Anjali Yadav
MEDICAL DEVICE APPROVAL PROCEDURE 70 Anjali Yadav
Categorize the Medical Device Identify the class of device a per PMD act and Japanese Medical Device Nomenclature (JMDN) Codes Establish QMS requirements that comply with the PMD Act and MHLW Obtain Necessary authorization and licenses Appoint an MAH: Class – 1 device not require MAH , While all other class devices require MAH for registration 71 Anjali Yadav
Submit the authorization documents according to requirements, all documents must be in Japanese Foreign Manufacturers shall submit Foreign Manufacture Registration (FMR) Request a QMS Inspection Class – 1 – Do not require Class – 2 – QMS audit by Registered Certification Body (RCB) Class – 3 & 4- QMS audit by PMDA On site audits are typically required for “NEW” devices with no existing JMDN Code, Class – 4 devices. And those requiring clinical investigation 72 Anjali Yadav
If Manufacturer get an approval from authority, then manufacture market their product into Japanese Market Submit the authorization documents according to requirements, all documents must be in Japanese 73 Anjali Yadav
REFERENCE 1. Medical Device Registration Processes of Japan: A Comparative Study with U. S. A. and Europe https://globalresearchonline.net/ijpsrr/v 79-1/17.pdf 2. The Drug Approval Process In Japan https://credevo.com/articles/2020/04/15/t he-drug-approval-process-in-japan/ 3. Generic drug approval process in Japan https://www.researchgate.net/figure/Gene ric-drug-approval-process-in-Japan- Main-Data-Required-for-the-Approval- of-Generic_fig3_325145465 4.PMDA Organisation https://www.pmda.go.jp/english/about- pmda/outline/0003.html 5. Pharmaceutical Laws and Regulations https://www.jpma.or.jp/english/about/parj /eki4g6000000784o-att/2020e_ch02.pdf 74 Anjali Yadav
75 ありがとう Anjali Yadav

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JAPAN: ORGANISATION OF PMDA, PHARMACEUTICAL LAWS & REGULATIONS, TYPES OF REGISTRATION APPLICATION

  • 1.
    JAPAN: ORGANISATION OF PMDA,PHARMACEUTICAL LAWS & REGULATIONS, TYPES OF REGISTRATION APPLICATION PARUL INSTITUTE OF PHARMACY PRESENTED BY: Anjali Yadav 2nd Sem M.PHARM Regulatory Affairs 1 Anjali Yadav
  • 2.
  • 3.
    INTRODUCTION PMDA (Pharmaceuticals andMedical Devices Agency) is Japanese regulatory agency, working together with Ministry of health and labour welfare (MHLW). The PMDA was established in April 2004 in order to serve in areas of review of drugs and medical devices, post – marketing safety measures, relief services for adverse health effects. There obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices. The role of the PMDA is to provide concerning the clinical trials of new drugs and medical devices, and to conduct approval reviews and surveys of the reliability of application data. 3 Anjali Yadav
  • 4.
    FUNCTIONS • Drug andmedical device testing • Scientific review of market authorization applications based on Japanese Pharmaceutical law • Advice in clinical trials or in the preparation of dossiers for the registration procedure (NDA) • Inspection and Conformity assessment of Good Clinical Practice (GCP), Good Laboratory Practice (GLP) & Good Practice Systems and programs (GPSP) • Auditing of manufacturers to ensure they conform to Good Manufacturing Practice (GMP) and have a suitable Quality Management System (QMS). 4 Anjali Yadav
  • 5.
    PMDA TRIANGLE SYSTEM REVIEW RELIEF SAFETY SAFETY TRIANGLE SYSTEM PMDAfocuses on 3 key services which is a Safety Triangle System. 5 Anjali Yadav
  • 6.
    PHARMACEUTICAL LAWS AND REGULATIONS Pharmaceuticaladministration in Japan is based on various laws and regulations, consisting mainly of: • Pharmaceutical and Medical Device Act • Law Concerning the Establishment for Pharmaceuticals and Medical Devices Organization • Law Concerning Securing Stable Supply of Blood Products • Poisonous and Deleterious Substances Control Law • Narcotics and Psychotropics Control Law • Cannabis Control Law • Opium Law • Stimulants Control Law 6 Anjali Yadav
  • 7.
    PHARMACEUTICAL LAWS AND REGULATIONS 7 1.Pharmaceutical and Medical Device Act The Pharmaceutical and Medical Device Act are to improve public health through regulations required to assure quality, efficacy, and safety of drugs, quasi-drugs, cosmetics, medical devices, and regenerative medicine products and to prevent hazard and expansion of hazard in public health caused by use of those products, as well as through measures required to promote R&D of drugs, medical devices and regenerative medicine products. Anjali Yadav
  • 8.
    PHARMACEUTICAL LAWS AND REGULATIONS 8 2.Law Concerning the Establishment for Pharmaceuticals and Medical Devices Organization This law establishes the Pharmaceuticals and Medical Devices Agency (PMDA), which is responsible for the evaluation and approval of pharmaceuticals and medical devices in Japan. The PMDA conducts reviews of new drug applications, monitors post-market safety, and enforces regulatory compliance to protect public health. Anjali Yadav
  • 9.
    PHARMACEUTICAL LAWS AND REGULATIONS 9 3.Law Concerning Securing Stable Supply of Blood Products This law governs the collection, processing, storage, and distribution of blood and blood products in Japan. It aims to ensure the safety and availability of blood products for medical use while safeguarding the health of blood donors and recipients. Anjali Yadav
  • 10.
    PHARMACEUTICAL LAWS AND REGULATIONS 10 4.Poisonous and Deleterious Substances Control Law This law regulates the handling, storage, transportation, and disposal of poisonous and deleterious substances in Japan. It establishes controls to prevent misuse, accidents, and environmental contamination associated with these substances, which include hazardous chemicals, pesticides, and industrial materials. Anjali Yadav
  • 11.
    PHARMACEUTICAL LAWS AND REGULATIONS 11 5.Narcotics and Psychotropics Control Law This law regulates the production, import, export, distribution, and prescription of narcotics and psychotropic substances in Japan. It aims to prevent drug abuse, trafficking, and diversion while ensuring access to controlled substances for legitimate medical purposes under strict supervision and regulation. Anjali Yadav
  • 12.
    PHARMACEUTICAL LAWS AND REGULATIONS 12 6.Cannabis Control Law: This law prohibits the cultivation, possession, sale, and use of cannabis (marijuana) in Japan. It imposes penalties for violations and establishes controls to prevent the misuse and diversion of cannabis, which is classified as a controlled substance with no recognized medical use under Japanese law. Anjali Yadav
  • 13.
    PHARMACEUTICAL LAWS AND REGULATIONS 13 7.Opium Law: Similar to the Narcotics and Psychotropics Control Law, the Opium Law regulates the production, import, export, distribution, and prescription of opium and its derivatives in Japan. It aims to prevent opium abuse and diversion while allowing for medical use under strict regulation and supervision. Anjali Yadav
  • 14.
    PHARMACEUTICAL LAWS AND REGULATIONS 14 8.Stimulants Control Law: This law regulates the production, import, export, distribution, and prescription of stimulant drugs, such as amphetamines and methamphetamines, in Japan. It aims to prevent stimulant abuse, trafficking, and diversion while ensuring access to these drugs for legitimate medical purposes under strict supervision and regulation. Anjali Yadav
  • 15.
    TYPES OF REGISTRATION APPLICATION Japan hasa well-established regulatory framework governing the approval and marketing of pharmaceutical products. The Pharmaceuticals and Medical Devices Agency (PMDA), along with the Ministry of Health, Labor, and Welfare (MHLW), oversees the registration process for pharmaceuticals. Various types of registration applications are required depending on the stage of drug development and intended use. 15 Anjali Yadav
  • 16.
    TYPES OF REGISTRATION APPLICATION Investigational NewDrug New Drug Application Abbreviated New Drug Application Biologic License Application (BLA) Orphan Drug Medical Device 16 Anjali Yadav
  • 17.
    INVESTIGATIONAL NEW DRUG • TheJapanese regulatory authority follows the Common Technical Document (CTD) drug application format and hence the applicant should prepare the Investigational New Drug (IND) application and documents as per the CTD format. • For drugs that are still in the testing Phase. • The primary objective of the IND application is to obtain approval from the regulatory authorities to conduct clinical trials with investigational drugs in Japan. This application serves to ensure the safety and efficacy of the drug candidates before they are administered to human subject. 17 Anjali Yadav
  • 18.
    COMPONENTS OF INVESTIGATIONAL NEW DRUGAPPLICATION 1. Chemical and Pharmaceutical Information 2. Nonclinical data 3. Clinical study Protocol 4. Investigator’s Brochure 18 Anjali Yadav
  • 19.
    COMPONENTS OF INVESTIGATIONAL NEW DRUGAPPLICATION 1. Chemical and Pharmaceutical Information: Detailed information regarding the chemical composition of the investigational drug, its manufacturing process, and its pharmaceutical form is provided in the application. 2. Nonclinical Data: Preclinical studies play a crucial role in evaluating the safety profile of the investigational drug. This section of the application includes data from pharmacology, toxicology, and pharmacokinetics studies conducted in laboratory settings. 19 Anjali Yadav
  • 20.
    COMPONENTS OF INVESTIGATIONAL NEW DRUGAPPLICATION 3. Clinical Study Protocol: A well-defined clinical study protocol outlines the objectives, study design, dosing regimen, and safety monitoring procedures for the proposed clinical trials. It also includes information on patient eligibility criteria and study endpoints. 4. Investigator's Brochure: This document provides comprehensive information about the investigational drug, including its pharmacological properties, pharmacokinetics, and safety profile. It serves as a reference for investigators conducting clinical trials. 20 Anjali Yadav
  • 21.
  • 22.
    Basic Investigation Screening Tests Studyof Manufacturing techniques/Formulations and Pharmaceutical Research Phytochemistry, Toxicity on GLP, Pharmacology & Pharmacokinetics Evaluation of Non – Clinical Studies INVESTIGATIONAL NEW DRUG APPROVAL PROCESS 22 Anjali Yadav
  • 23.
    Clinical Trial Notificationto PMDA Receipt of Notification Review of Notification Guidance on Investigation Required INVESTIGATIONAL NEW DRUG APPROVAL PROCESS 23 Anjali Yadav
  • 24.
    NEW DRUG APPLICATION •A New Drug Application (NDA) is a pivotal document submitted by a pharmaceutical company to regulatory authorities, such as the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, seeking approval to market and distribute a new pharmaceutical product. • This comprehensive application serves as the primary vehicle through which the company communicates essential information about the new drug to the regulatory agency, demonstrating its safety, efficacy, and quality for the intended therapeutic use. 24 Anjali Yadav
  • 25.
    COMPONENTS OF NEW DRUGAPPLICATION 1. Chemistry, Manufacturing, and Controls (CMC) Information 2. Nonclinical Pharmacology and Toxicology Studies 3. Clinical Data 4. Drug Labelling and Prescribing Information 5. Risk Management Plan (RMP) 6. Regulatory Commitments 25 Anjali Yadav
  • 26.
    COMPONENTS OF NEW DRUGAPPLICATION 1. Chemistry, Manufacturing, and Controls (CMC) Information: This section provides detailed data on the composition, manufacturing process, and quality control measures of the new drug. It encompasses information on the drug substance, drug product formulation, manufacturing facilities, and analytical methods used to assess product quality and stability. 26 Anjali Yadav
  • 27.
    COMPONENTS OF NEW DRUGAPPLICATION 2. Nonclinical Pharmacology and Toxicology Studies: Preclinical data from pharmacological and toxicological studies conducted in laboratory animals are included to assess the drug's pharmacological activity, potential toxicity, and safety profile. These studies provide crucial insights into the drug's mechanism of action, potential side effects, and dose-response relationships. 27 Anjali Yadav
  • 28.
    COMPONENTS OF NEW DRUGAPPLICATION 3. Clinical Data: The cornerstone of the NDA is the clinical data obtained from human trials conducted during the drug development process. These studies are designed to evaluate the drug's safety and efficacy in patients with the target disease or condition. The NDA includes detailed summaries of clinical trial protocols, results, and analyses, along with safety monitoring data and adverse event reports. 28 Anjali Yadav
  • 29.
    COMPONENTS OF NEW DRUGAPPLICATION 4. Drug Labelling and Prescribing Information: The proposed labelling for the new drug, including package inserts, prescribing information, and patient information leaflets, is provided in the NDA. This information outlines essential details such as indications, dosage and administration instructions, contraindications, warnings, precautions, and potential adverse reactions associated with the use of the drug. 29 Anjali Yadav
  • 30.
    COMPONENTS OF NEW DRUGAPPLICATION 5. Risk Management Plan (RMP): In some cases, especially for drugs with complex safety profiles or significant risks, the NDA may include a risk management plan aimed at minimizing and managing potential risks associated with the drug's use. The RMP outlines specific pharmacovigilance activities, risk minimization strategies, and post-marketing surveillance plans to ensure ongoing evaluation of the drug's safety profile. 30 Anjali Yadav
  • 31.
    COMPONENTS OF NEW DRUGAPPLICATION 6. Regulatory Commitments: The NDA may also include commitments from the pharmaceutical company to conduct additional post-approval studies, implement risk mitigation measures, or provide further data to address specific regulatory concerns raised during the review process 31 Anjali Yadav
  • 32.
  • 33.
    Application PMDA Approval Review MHLW Evaluation & Licensing Compliance Review GMPReview Pharmaceutical Affairs and Food Sanitation Council Experts Evaluation Committees Pharmaceutical Affairs Section Consultation Enquiry Response Minister of MHLW (Final Evaluation) Approval NEW DRUG APPLICATION APPROVAL PROCESS 33 Anjali Yadav
  • 34.
    ABBREVIATED NEW DRUG APPLICATION •In Japan, the PMDA reviews generic drug applications, and this includes the assessment of bioequivalence studies. This bioequivalence assessment helps to confirm the quality, efficacy, and safety of the product based on documents submitted by applicants. • In Japan, the drug product is considered to be a generic drug, if it covers the following criteria: • It contains an API (Active Pharmaceutical Ingredient), • If the API has a different hydrate form or crystalline form from the original drug, and • If the API has the same chemical structure as the original drug 34 Anjali Yadav
  • 35.
    COMPONENTS OF ABBREVIATED NEWDRUG APPLICATION 1. Product Development 2. Bioequivalence studies 3. Quality Control and Manufacturing 4. Regulatory submission 5. Review Process 35 Anjali Yadav
  • 36.
    COMPONENTS OF ABBREVIATED NEWDRUG APPLICATION 1. Product Development: Generic drug manufacturers in Japan begin the development process by identifying a reference product, usually a branded drug that has already been approved and marketed. They then work to replicate the active pharmaceutical ingredients (APIs) and formulation of the reference product. 36 Anjali Yadav
  • 37.
    COMPONENTS OF ABBREVIATED NEWDRUG APPLICATION 2. Bioequivalence Studies: Similar to the requirements in the United States, demonstrating bioequivalence is a critical aspect process in Japan. Bioequivalence studies compare the pharmacokinetic parameters of the generic product with those of the reference product to ensure that they are equivalent in terms of rate and extent of absorption. 37 Anjali Yadav
  • 38.
    COMPONENTS OF ABBREVIATED NEWDRUG APPLICATION 3. Quality Control and Manufacturing: The generic drug manufacturer must adhere to strict quality control standards and Good Manufacturing Practice (GMP) regulations throughout the manufacturing process to ensure the consistency and quality of the finished product. 38 Anjali Yadav
  • 39.
    COMPONENTS OF ABBREVIATED NEWDRUG APPLICATION 4. Regulatory Submission: Once the generic drug has been developed and bioequivalence has been demonstrated through studies, the manufacturer submits a Generic Drug Application to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. This application includes comprehensive data on the product's formulation, manufacturing process, bioequivalence studies, stability data, and other relevant information. 39 Anjali Yadav
  • 40.
    COMPONENTS OF ABBREVIATED NEWDRUG APPLICATION 5. Review Process: The PMDA conducts a thorough review of the Generic Drug Application to assess the quality, safety, and efficacy of the generic product. This review process involves evaluating the submitted data against regulatory standards and requirements to determine whether the generic drug meets the necessary criteria for approval. 40 Anjali Yadav
  • 41.
  • 42.
    Applicant Application Incorporate Administrative Agency PMDA(Pharmaceutical & Medical Device Agency) Outcome of Inspection MHLW GCP/ GLP/GMP Audit & Compliance Foreign Site Manufacturing Plant Prefectural Government Domestic Site GMP Inspection Outcome of Review APPROVAL ABBREVIATED NEW DRUG APPLICATION APPROVAL PROCESS 42 Anjali Yadav
  • 43.
    BIOLOGICS LICENSE APPLICATION • ThePMDA’s office of biologicals provides consultations concerning clinical trials of new biologic drugs and handles biotechnology medicines, which includes biosimilars. • Requirements for biologic drugs differ from general drugs and depend on whether a biological product is a regenerative medicine product or not. • The MHLW designates a product as a biological drug after its consultation with the Pharmaceutical Affairs and Food Sanitation Council (PAFSC). 43 Anjali Yadav
  • 44.
    BIOLOGICS LICENSE APPLICATION • Biosimilardrugs: • Biosimilar drugs are considered as those drugs that are “equivalent and homogenous to the reference biological product in terms of efficacy, quality, and safety.” • In Japan, the approval of biosimilar products tends to reduce the amount of new information required and the timeline for approval. • The applicant can reduce the burden in case if it has information gathered for its foreign license or approval. 44 Anjali Yadav
  • 45.
    COMPONENTS OF BIOLOGICS LICENSEAPPLICATION 1. Product Development 2. Clinical Trials 3. Quality Control and Manufacturing 4. Comparative Studies 5. Post-Marketing Commitments 6. Labelling and Packaging 7. Risk Management Plan (RMP) 45 Anjali Yadav
  • 46.
    COMPONENTS OF BIOLOGICS LICENSEAPPLICATION 1. Product Development: Biologics are complex therapeutic products derived from living organisms or their components, such as proteins, nucleic acids, or cells. Product development involves extensive research and development to characterize the biologic, establish manufacturing processes, and conduct preclinical studies to assess safety and efficacy. 46 Anjali Yadav
  • 47.
    COMPONENTS OF BIOLOGICS LICENSEAPPLICATION 2. Clinical Trials: Clinical development for biologics typically involves conducting clinical trials to evaluate safety and efficacy in patients with the target disease or condition. These trials are designed to generate robust data on the biologic's therapeutic effects, dosing regimens, and safety profile. 47 Anjali Yadav
  • 48.
    COMPONENTS OF BIOLOGICS LICENSEAPPLICATION 3. Quality Control and Manufacturing: Ensuring the quality and consistency of biologic products is essential. Manufacturers must adhere to strict quality control standards and Good Manufacturing Practice (GMP) regulations throughout the manufacturing process to produce biologics that meet regulatory requirements. 48 Anjali Yadav
  • 49.
    COMPONENTS OF BIOLOGICS LICENSEAPPLICATION 4. Comparative Studies: In addition to demonstrating the safety and efficacy of the biologic product, comparative studies may be required to establish similarity or comparability to a reference product, especially if the biologic is a biosimilar or interchangeable product. These studies assess similarities in quality attributes, pharmacokinetics, pharmacodynamics, and immunogenicity between the biologic and the reference product. 49 Anjali Yadav
  • 50.
    COMPONENTS OF BIOLOGICS LICENSEAPPLICATION 5. Post-Marketing Commitments: Regulatory authorities may request post-marketing commitments as a condition for approval, particularly for novel or complex biologics. These commitments may include additional safety monitoring, pharmacovigilance studies, real-world evidence generation, or further clinical trials to address specific concerns or uncertainties identified during the review process. 50 Anjali Yadav
  • 51.
    COMPONENTS OF BIOLOGICS LICENSEAPPLICATION 6. Labelling and Packaging: The BLA submission includes proposed labeling and packaging information for the biologic product. This includes prescribing information, dosage instructions, contraindications, warnings, precautions, adverse reaction information, and other essential details intended for healthcare professionals and patients. 51 Anjali Yadav
  • 52.
    COMPONENTS OF BIOLOGICS LICENSEAPPLICATION 7. Risk Management Plan (RMP): A comprehensive risk management plan may be required, particularly for biologics with complex safety profiles or unique risks. The RMP outlines strategies and measures to identify, minimize, and manage risks associated with the use of the biologic product throughout its lifecycle, including post-marketing surveillance and risk mitigation activities. 52 Anjali Yadav
  • 53.
  • 54.
    Applicant Fulfil all requirementsfor Biosimilars Application Ministry of Health and Labour Welfare (MHLW) PMDA Review and Manufacturing Inspection BIOLOGICS LICENSE APPLICATION APPROVAL PROCESS 54 Anjali Yadav
  • 55.
    Schedule Meeting withApplicant Complete detailed review report MHLW’s Pharmaceutical & Food Safety Bureau Forward Report MHLW’s Review APPROVE BIOLOGICS LICENSE APPLICATION APPROVAL PROCESS 55 Anjali Yadav
  • 56.
    ORPHAN DRUG • Japandefines a disease as rare if fewer than 50,000 people are affected. Pharmaceutical companies can request orphan drug designation to treat such rare diseases. • Criteria for drugs to obtain orphan drug designation • The medical need is very high. • The intended use is for severe diseases • In addition, the drug needs to meet the following conditions • No other drug or medical treatment is available for the disease. • The product under review exhibits significantly high efficacy and safety compared with existing products. • There exists a strong rationale for the use of the product. 56 Anjali Yadav
  • 57.
    COMPONENTS OF ORPHAN DRUGAPPLICATION 1. Orphan Drug Designation 2. Clinical Development 3. Priority Review and Approval 4. Post-Marketing Commitments 57 Anjali Yadav
  • 58.
    COMPONENTS OF ORPHAN DRUGAPPLICATION 1. Orphan Drug Designation: Before submitting an application for approval, the drug must first receive orphan designation from the PMDA. This designation is granted to drugs intended for the treatment, diagnosis, or prevention of rare diseases that affect a small number of patients in Japan. The criteria for orphan designation are outlined in the "Orphan Drug Designation System" provided by the PMDA. 58 Anjali Yadav
  • 59.
    COMPONENTS OF ORPHAN DRUGAPPLICATION 2. Clinical Development: Similar to the development of non- orphan drugs, clinical studies are conducted to evaluate the safety and efficacy of the orphan drug. However, given the challenges of conducting clinical trials for rare diseases with limited patient populations, the PMDA may accept smaller or less conventional trial designs, such as single-arm studies or studies with surrogate endpoints. 59 Anjali Yadav
  • 60.
    COMPONENTS OF ORPHAN DRUGAPPLICATION 3. Priority Review and Approval: Orphan drugs may be eligible for priority review by the PMDA, which expedites the review process to accelerate access to treatment for patients with rare diseases. The PMDA evaluates the orphan drug application based on its scientific merit, clinical data, and the unmet medical need for patients with the rare disease. 60 Anjali Yadav
  • 61.
    COMPONENTS OF ORPHAN DRUGAPPLICATION 4. Post-Marketing Commitments: As a condition for approval, the PMDA may request post-marketing commitments, such as additional safety monitoring or long-term efficacy studies, to further evaluate the orphan drug's benefit-risk profile in real- world clinical practice. 61 Anjali Yadav
  • 62.
    MEDICAL DEVICE • Registrationof Medical devices and pharmaceuticals in Japan is complicated, and high costs and long timeframes. • In some cases, Japanese regulators require clinical trials in Japan to be conducted. • Product registration in Japan needs to be pursued carefully and only after determining that there is a strong market demand for your product. • In order to market medical devices in Japan, a foreign manufacturer has to obtain approval/certification or submit notification. 62 Anjali Yadav
  • 63.
    Class – 1Class – 2 Class – 3 Class – 4 General Medical Device Controlled Medical Device Specially Controlled Medical Device Specially Controlled Medical Device Extremely Low Risk Low Risk Medium Risk High Risk 63 Anjali Yadav
  • 64.
    Nebulizers, X- ray film X-ray imaging device, injection needle, Ultrasonic diagnostic device Artificial dialyzer, Infusion Pump, Artificial Bone Pacemaker, Coronary stent, Artificial Blood vessel Self Declaration Third Party Certification Ministers Approval Third Party Certification Ministers Approval 64 Anjali Yadav
  • 65.
    REGISTRATION PROCEDURE FOR MEDICALDEVICES The registration pathway for your device is determined by its classification and associated Japan Medical Device Nomenclature (JMDN). To market medical devices in Japan, your Marketing Authorization Holder (MAH) must register your device through one of the following procedures. 65 Anjali Yadav
  • 66.
    REGISTRATION PROCEDURE FOR MEDICALDEVICE Premarket Notification (Todoke) Pre-market certification (Ninsho) Pre-market approval (Shonin) 66 Anjali Yadav
  • 67.
    REGISTRATION PROCEDURE FOR MEDICALDEVICE 1. Premarket Notification (Todoke) To register General Medical Devices (Class I), you must file a pre-market submission to the PMDA. There is No review/assessment by the PMDA will be conducted. 67 Anjali Yadav
  • 68.
    REGISTRATION PROCEDURE FOR MEDICALDEVICE 2. Premarket Certification (Ninsho) Class II (and a limited number of Class III) devices which have an associated certification standard (JIS), are subject to pre- market certification. Many, but not all, Japan Industrial Standards are based on existing ISO/IEC standards. MAH will file the application with a Registered Certification Body (RCB). The process is similar to the European CE marking process where reviews are outsourced to a third party similar to a Notified Body. 68 Anjali Yadav
  • 69.
    REGISTRATION PROCEDURE FOR MEDICALDEVICE 3. Premarket Approval (Shonin) Class II and III devices without a specific certification standard are subject to the pre-market approval process. This also applies to all Class IV devices. In this case your MAH will file a pre-market approval application with the PMDA and ultimately obtain approval from the MHLW. 69 Anjali Yadav
  • 70.
  • 71.
    Categorize the MedicalDevice Identify the class of device a per PMD act and Japanese Medical Device Nomenclature (JMDN) Codes Establish QMS requirements that comply with the PMD Act and MHLW Obtain Necessary authorization and licenses Appoint an MAH: Class – 1 device not require MAH , While all other class devices require MAH for registration 71 Anjali Yadav
  • 72.
    Submit the authorizationdocuments according to requirements, all documents must be in Japanese Foreign Manufacturers shall submit Foreign Manufacture Registration (FMR) Request a QMS Inspection Class – 1 – Do not require Class – 2 – QMS audit by Registered Certification Body (RCB) Class – 3 & 4- QMS audit by PMDA On site audits are typically required for “NEW” devices with no existing JMDN Code, Class – 4 devices. And those requiring clinical investigation 72 Anjali Yadav
  • 73.
    If Manufacturer getan approval from authority, then manufacture market their product into Japanese Market Submit the authorization documents according to requirements, all documents must be in Japanese 73 Anjali Yadav
  • 74.
    REFERENCE 1. Medical DeviceRegistration Processes of Japan: A Comparative Study with U. S. A. and Europe https://globalresearchonline.net/ijpsrr/v 79-1/17.pdf 2. The Drug Approval Process In Japan https://credevo.com/articles/2020/04/15/t he-drug-approval-process-in-japan/ 3. Generic drug approval process in Japan https://www.researchgate.net/figure/Gene ric-drug-approval-process-in-Japan- Main-Data-Required-for-the-Approval- of-Generic_fig3_325145465 4.PMDA Organisation https://www.pmda.go.jp/english/about- pmda/outline/0003.html 5. Pharmaceutical Laws and Regulations https://www.jpma.or.jp/english/about/parj /eki4g6000000784o-att/2020e_ch02.pdf 74 Anjali Yadav
  • 75.