Regulatory affairs, Regulatory requirements for drug approval.pptx

Regulatory affairs, Regulatory
requirements for drug
approval.
Prepared by: Mr. Pawan Dhamala
Department of Pharmaceutics
5/13/2023 Regulatory Affairs & Regulatory requirements for drug approval 1

Regulatory Affairs
• Regulatory affairs refer to the set of activities, processes, and strategies that
ensure compliance with government regulations and laws related to
products, services, and processes.
• The regulatory affairs department is responsible for keeping up to date with
the latest regulations, policies, and guidelines that affect the organization's
operations.
• The primary objective of regulatory affairs is to ensure that products,
processes, and services meet the required safety and efficacy standards and
are consistent with applicable laws and regulations.
• This includes the registration, licensing, and authorization of products, as
well as the development and implementation of quality systems and
compliance programs.

• Regulatory affairs also involves communicating with regulatory agencies,
such as the FDA, EMA, and other regulatory authorities, to ensure that the
organization complies with all requirements and receives timely approvals
for their products and services. It plays a crucial role in the development
and launch of new products and services, as well as the ongoing
maintenance and compliance of existing ones.
• In summary, regulatory affairs is a critical function in any organization that
deals with regulated products or services, ensuring that they are compliant
with the latest regulatory requirements and guidelines, and facilitating their
successful approval and launch.

Historical overview of regulatory affairs
USA HISTORICAL OVERVIEW
• The history of regulatory affairs can be traced back to the early 20th
century when the first drug and food regulations were introduced in the
United States.
• The passage of the 1906 Pure Food and Drug Act in the US was a
significant milestone in this area, as it established the regulatory
framework for ensuring the safety and efficacy of food and drugs.
• This act was later amended and expanded with the introduction of the
Food, Drug, and Cosmetic Act in 1938, which created the US Food and
Drug Administration (FDA) to oversee the regulation of food, drugs, and
cosmetics.

• The 1960s and 1970s saw a significant expansion in the regulatory
environment, with the introduction of new regulations related to medical
devices, biologics, and other products.
• This period also saw the establishment of international regulatory bodies,
such as the International Conference on Harmonisation (ICH), which
aimed to promote the harmonization of regulatory requirements across
different countries.
• The 1980s and 1990s saw a shift towards a more risk-based approach to
regulation, with a greater emphasis on pre-market approval and post-
market surveillance.
• The introduction of the US Prescription Drug User Fee Act (PDUFA) in
1992 was a significant development in this area, as it allowed the FDA to
collect fees from drug manufacturers to fund the review and approval
process for new drugs.

• The 21st century has seen a continued focus on risk-based regulation, with a
growing emphasis on the use of new technologies, such as genomics and
personalized medicine. The development of new regulatory frameworks,
such as the FDA's breakthrough therapy designation, has also facilitated the
expedited approval of innovative new products.
• Overall, the history of regulatory affairs has been marked by a steady
evolution towards a more comprehensive and risk-based approach to
regulation, with an increasing emphasis on international cooperation and the
use of new technologies.
INDIA HISTORICAL OVERVIEW
Regulatory affairs in India has undergone significant changes over the years,
particularly in the pharmaceutical and medical device sectors.

• In 1940, the Drugs and Cosmetics Act was enacted, which provided the
framework for the regulation of drugs and cosmetics in India. In 1961, the
act was amended to introduce a system of pre-market approval for new
drugs, and the Central Drugs Standard Control Organization (CDSCO) was
established to oversee the regulation of drugs in India.
• In 1995, the Indian government introduced a policy of liberalization, which
led to the growth of the pharmaceutical industry in India. The government
also introduced a series of reforms to improve the regulatory framework,
including the establishment of the National Pharmaceutical Pricing
Authority (NPPA) in 1997 to regulate drug prices.
• In 2005, the Indian government introduced the Patents (Amendment) Act,
which brought India's patent law in line with international standards. This
act also introduced data exclusivity provisions, which granted protection to
clinical trial data submitted to the regulatory authorities.

• In 2010, the Indian government introduced the New Drugs and Clinical
Trials Rules, which streamlined the approval process for new drugs and
clinical trials. The rules also established a system of ethics committees to
oversee the conduct of clinical trials in India.
• In 2017, the Indian government introduced the Medical Devices Rules,
which provided the regulatory framework for the registration and approval
of medical devices in India. The rules also established the Medical Devices
Technical Advisory Group (MDTAG) to provide technical guidance to the
CDSCO.
• Overall, regulatory affairs in India has evolved to keep pace with the
changing landscape of the pharmaceutical and medical device industries.
The Indian regulatory authorities continue to implement reforms and
initiatives to improve the regulatory framework, with a focus on ensuring
the safety and efficacy of drugs and medical devices, while promoting
innovation and growth in these sectors.

Regulatory Authorities
• Regulatory authorities are government agencies or bodies responsible for
overseeing and enforcing regulations, laws, and guidelines related to
specific industries, products, or services. These authorities play a critical
role in ensuring that companies comply with the required standards and
regulations, promoting public health and safety, and protecting consumers
and the environment.
• Some of the key regulatory authorities at the national and international
levels include:

• Food and Drug Administration (FDA) - The FDA is a regulatory agency
of the US government responsible for the regulation of food, drugs, and
medical devices in the United States.
• European Medicines Agency (EMA) - The EMA is a regulatory agency of
the European Union responsible for the scientific evaluation, supervision,
and safety monitoring of medicines in the European Economic Area.
• Health Canada - Health Canada is a regulatory authority of the Canadian
government responsible for the regulation of health products, including
drugs, medical devices, and natural health products.
• Central Drugs Standard Control Organization (CDSCO) - The CDSCO
is the regulatory authority responsible for the regulation of drugs and
medical devices in India.
• Ministry of Health, Labour and Welfare (MHLW) - The MHLW is a
regulatory authority of the Japanese government responsible for the
regulation of pharmaceuticals, medical devices, and food products in Japan.

• China Food and Drug Administration (CFDA) - The CFDA is the
regulatory authority responsible for the regulation of drugs and medical
devices in China.
• International Conference on Harmonisation (ICH) - The ICH is an
international regulatory body responsible for the harmonization of
regulatory requirements for drugs and pharmaceuticals in the United States,
Europe, and Japan.

Role of regulatory affairs department
• Product Registration: The regulatory affairs department is responsible for
obtaining necessary approvals and registrations for products and services
from the regulatory authorities, including product classification, labeling,
and advertising.
• Regulatory Compliance: The regulatory affairs department is responsible
for ensuring that all products and services comply with the relevant
regulations, guidelines, and standards set by the regulatory authorities. This
includes monitoring and reporting any changes to the regulatory
environment that may impact the company's products and services.
• Quality Control: The regulatory affairs department works closely with the
quality control and quality assurance departments to ensure that products
and services meet the required quality standards, including product safety,
efficacy, and performance

• Clinical Trials: The regulatory affairs department is responsible for
obtaining necessary approvals and permits for clinical trials and ensuring
that these trials are conducted in compliance with the relevant regulations
and guidelines.
• Risk Management: The regulatory affairs department is responsible for
identifying and managing risks associated with products and services,
including adverse events and product recalls, and reporting these to the
relevant regulatory authorities.
• Intellectual Property: The regulatory affairs department is responsible for
managing the company's intellectual property portfolio, including patents,
trademarks, and copyrights, and ensuring that these are protected and
maintained in compliance with the relevant regulations.

Regulatory requirement for drug approval
The regulatory requirements for drug approval vary depending on the
country or region where the drug is being developed and marketed. In
general, the following are the key steps in the drug approval process:
• Preclinical Testing: Before a drug can be tested in humans, it must
undergo preclinical testing in animals to assess its safety and efficacy.
• Investigational New Drug (IND) Application: An IND application must
be submitted to the regulatory authorities to begin clinical trials in
humans. The IND application includes information on the drug's safety
and efficacy in preclinical studies, as well as its manufacturing and
quality control.
• Clinical Trials: The drug must undergo several phases of clinical trials to
assess its safety and efficacy in humans. The trials are designed to gather
data on the drug's pharmacokinetics, pharmacodynamics, dosing, and
adverse effects.

• New Drug Application (NDA) or Marketing Authorization Application
(MAA): After the completion of clinical trials, the drug developer submits
an NDA or MAA to the regulatory authorities for approval to market the
drug. The application includes data on the drug's safety and efficacy in
clinical trials, as well as its manufacturing and quality control.
• Review and Approval: The regulatory authorities review the NDA or MAA
and may request additional data or information. If the drug meets the
necessary regulatory requirements, it is approved for marketing.
• Post-Marketing Surveillance: Once the drug is on the market, the
regulatory authorities continue to monitor its safety and efficacy through
post-marketing surveillance, including adverse event reporting and
pharmacovigilance.

Drug development team
A drug development team is a multidisciplinary group of professionals responsible for
developing a new drug from concept to market approval. The team typically includes
individuals from a range of scientific, medical, and business backgrounds.
Here are some of the key roles and responsibilities of the members of a drug development
team:
• Project Manager: The project manager is responsible for overseeing the overall drug
development process and ensuring that the project is completed on time and within budget.
• Medical Affairs: Medical affairs professionals are responsible for providing medical and
scientific support to the drug development team, including clinical development and
medical writing.
• Regulatory Affairs: Regulatory affairs professionals are responsible for ensuring that the
drug is developed in compliance with the relevant regulatory requirements and standards,
and for submitting regulatory applications for approval.
• Clinical Development: Clinical development professionals are responsible for designing
and conducting clinical trials to evaluate the safety and efficacy of the drug in humans

• Research and Development: Research and development professionals are
responsible for discovering and developing the drug, including conducting
preclinical studies to assess its safety and efficacy.
• Manufacturing: Manufacturing professionals are responsible for developing
the drug's manufacturing process, ensuring its quality and consistency, and
scaling up production for commercialization.
• Quality Assurance and Control: Quality assurance and control
professionals are responsible for ensuring that the drug meets the necessary
quality standards, including product safety, efficacy, and performance.
• Business Development: Business development professionals are responsible
for identifying potential partners and opportunities for commercializing the
drug, including marketing, distribution, and licensing agreements.
Overall, a drug development team must work collaboratively to ensure the
successful development and commercialization of a new drug, while ensuring
that it meets the necessary regulatory and quality standards.

Non-Clinical Drug Development
Non-clinical drug development refers to the process of testing and evaluating a new drug
candidate in laboratory and animal studies before it is tested in humans. The goal of non-
clinical drug development is to provide critical safety and efficacy data on the drug before it
enters clinical trials. Here are some of the key steps involved in non-clinical drug
development:
1. Discovery and Lead Optimization: In the discovery phase, researchers identify a potential
drug target and develop compounds that interact with the target. In lead optimization, the most
promising compounds are selected and further optimized to improve their potency, selectivity,
and safety.
2. In vitro Studies: In vitro studies involve testing the drug in cell-based assays to assess its
activity and toxicity. These studies can also help to identify potential drug-drug interactions
and determine appropriate dosing.
3. Pharmacokinetic Studies: Pharmacokinetic studies assess how the drug is absorbed,
distributed, metabolized, and excreted in the body. These studies can help to determine
appropriate dosing and route of administration.

4. Pharmacology Studies: Pharmacology studies assess the drug's
mechanism of action, efficacy, and safety in animal models. These studies
can help to identify potential side effects and optimize dosing.
5. Toxicology Studies: Toxicology studies assess the drug's safety profile,
including its potential for toxicity and adverse effects. These studies are
typically conducted in animal models and involve testing the drug at various
doses and durations.
6. Formulation Development: Formulation development involves
developing a stable, safe, and effective formulation of the drug for
administration to patients.
7. Regulatory Submission: Non-clinical data is submitted to regulatory
authorities as part of an Investigational New Drug (IND) application, which
allows the drug to be tested in humans.
Overall, non-clinical drug development is a critical step in the drug
development process, providing important safety and efficacy data that
inform the design and conduct of clinical trials.

Pharmacology, Drug metabolism and Toxicology
Pharmacology, drug metabolism, and toxicology are key areas of non-clinical drug
development that are critical to ensuring the safety and efficacy of a new drug.
Here's an overview of each of these areas:
1. Pharmacology: Pharmacology is the study of how drugs interact with
biological systems to produce a therapeutic effect. In non-clinical drug
development, pharmacology studies are conducted to evaluate the drug's
mechanism of action, efficacy, and safety in animal models. These studies can help
to identify potential side effects and optimize dosing.
2. Drug Metabolism: Drug metabolism refers to the chemical transformation of a
drug in the body, which can affect its efficacy and toxicity. In non-clinical drug
development, pharmacokinetic studies are conducted to assess how the drug is
absorbed, distributed, metabolized, and excreted in the body. These studies can
help to determine appropriate dosing and route of administration.
3. Toxicology: Toxicology is the study of the adverse effects of chemicals on
living organisms. In non-clinical drug development, toxicology studies are
conducted to assess the drug's safety profile, including its potential for toxicity and
adverse effects. These studies are typically conducted in animal models and
involve testing the drug at various doses and durations.

General considerations of Investigational New Drug Applications
(IND)
An Investigational New Drug (IND) application is a regulatory submission that must
be filed with the US Food and Drug Administration (FDA) before a new drug can be
tested in humans. Here are some general considerations that need to be taken into
account when preparing an IND application:
• Safety: The safety of the drug must be evaluated in non-clinical studies before it
can be tested in humans. The IND application must provide data from these studies
that demonstrate the safety of the drug and its potential risks.
• Clinical trial design: The IND application must include a detailed clinical trial
plan, including the study design, inclusion/exclusion criteria, and dosing regimen.
The clinical trial plan should be designed to evaluate the safety and efficacy of the
drug.
• Manufacturing: The IND application must provide information on the drug's
manufacturing process and quality control procedures. This information is used to
ensure the consistency and quality of the drug throughout the clinical trial process.

• Chemistry, Manufacturing, and Controls (CMC): The CMC section of
the IND application must provide detailed information on the drug
substance, drug product, and manufacturing process. This information is
used to evaluate the drug's chemistry and ensure that it meets the necessary
quality standards.
• Investigator brochure: The IND application must include an investigator
brochure, which provides a comprehensive summary of the drug's
pharmacology, toxicology, and clinical trial data. The investigator brochure
is used by clinical investigators to guide their participation in the clinical
trial.
• Regulatory interactions: Sponsors of an IND application are encouraged to
engage in frequent communication with the FDA throughout the drug
development process. These interactions can help to ensure that the IND
application is complete and that the clinical trial design is appropriate.

IND Approval Process:

Investigator's brochure (IB)
An Investigator's Brochure (IB) is a comprehensive document that provides a summary
of the drug's pharmacology, toxicology, and clinical trial data. The IB is intended to
provide clinical investigators with all of the information they need to conduct a clinical
trial with the drug.
The IB typically includes the following information:
• Introduction: An overview of the drug and its intended use.
• Chemistry and manufacturing: Detailed information on the drug substance, drug
product, and manufacturing process.
• Pharmacology: A description of the drug's mechanism of action, pharmacokinetics,
pharmacodynamics, and potential interactions with other drugs.
• Toxicology: Information on the drug's safety profile, including results from non-
clinical studies.
• Clinical data: A summary of all available clinical data on the drug, including results
from previous clinical trials.
• Dosage and administration: Information on dosing regimens, routes of
administration, and drug interactions.
• Safety monitoring: A description of the safety monitoring procedures that will be
used during the clinical trial.
5/13/2023 24

The IB is a critical document in the drug development process, as it provides
clinical investigators with the information they need to ensure the safety &
efficacy of the drugs during clinical trials.

New Drug Application (NDA)
A New Drug Application (NDA) is a regulatory submission that must be
filed with the US Food and Drug Administration (FDA) in order to seek
approval for a new drug. The NDA is a comprehensive document that
provides detailed information on the drug's safety, efficacy, and
manufacturing.
The NDA includes the following information:
• Chemistry, Manufacturing, and Controls (CMC): A detailed description
of the drug substance, drug product, and manufacturing process, including
information on quality control and stability.
• Non-Clinical Studies: Data from non-clinical studies that evaluate the
drug's safety and toxicity profile.
• Clinical Data: Results from clinical trials that evaluate the drug's safety
and efficacy in humans.

• Proposed Labeling: The proposed labeling for the drug, including
indications, dosing, contraindications, warnings, precautions, and adverse
reactions.
• Statistical Analysis: A statistical analysis of the clinical trial data, including
methods used to analyze the data and results of the analysis.
• Regulatory Requirements: A summary of the regulatory requirements for
the drug, including any special considerations or restrictions.
The NDA is a complex document that requires significant resources to prepare.
The FDA reviews the NDA to ensure that the drug is safe and effective for its
intended use. Once the NDA is approved, the drug can be marketed and sold in
the United States.

NDAApproval Process:

Clinical Research
Clinical research is a branch of medical science that involves the study of
drugs, medical devices, and treatments in human subjects. The goal of clinical
research is to evaluate the safety and efficacy of new medical interventions
and to improve the understanding of human biology and disease.
Clinical research typically involves several stages, including:
1. Phase I clinical trials: These are the first studies of a new drug in humans.
The primary goal of Phase I trials is to evaluate the safety of the drug and to
identify the appropriate dosing regimen.
2. Phase II clinical trials: These studies evaluate the efficacy of the drug in a
small group of patients with the disease or condition being treated. Phase II
trials also provide additional information on the drug's safety profile.
3. Phase III clinical trials: These studies are large, randomized, controlled
trials that evaluate the safety and efficacy of the drug in a larger population of
patients. Phase III trials are often used to support the regulatory approval of a
new drug.

4. Phase IV clinical trials: These studies are conducted after a drug has been
approved and are designed to monitor the long-term safety and efficacy of the
drug.
Clinical research is tightly regulated to ensure the safety and welfare of human
subjects. All clinical trials must be approved by an institutional review board
(IRB) and must comply with local laws and regulations.
BIOEQUIVALANCE STUDIES(BE STUDIES)
• Bioequivalence studies are clinical trials designed to demonstrate that a
generic drug product is equivalent to its corresponding brand-name drug in
terms of safety and efficacy. These studies are required by regulatory
agencies, such as the US Food and Drug Administration (FDA), before a
generic drug can be approved for sale.

• The goal of bioequivalence studies is to demonstrate that the generic drug
product has the same pharmacokinetic profile (rate and extent of drug
absorption) as the brand-name drug. This is typically accomplished by
comparing the blood concentration of the active ingredient in the generic
drug product to that of the brand-name drug in a group of healthy volunteers.
• Bioequivalence studies are typically conducted using a randomized,
crossover design. This means that each subject receives both the generic drug
product and the brand-name drug in a randomized order, with a washout
period between treatments. The blood concentration of the active ingredient
is then measured over time and analyzed to determine if the generic drug
product is bioequivalent to the brand-name drug.
• If the bioequivalence study demonstrates that the generic drug product is
equivalent to the brand-name drug, it can be approved for sale and marketed
as a less expensive alternative to the brand-name drug. This helps to increase
access to affordable medications for patients while maintaining high
standards of safety and efficacy.

Clinical Research Protocol:
A clinical research protocol is a detailed plan that outlines the objectives,
design, methodology, statistical considerations, and ethical considerations of a
clinical trial. The protocol serves as a blueprint for the conduct of the study
and provides guidance to investigators, study staff, and regulatory authorities.

Biostatistics in Pharmaceutical Product Development
Biostatistics plays a critical role in pharmaceutical product
development, as it provides the analytical framework for designing,
conducting, and analyzing clinical trials. Biostatisticians use statistical
methods to ensure that clinical trials are conducted in a scientifically
rigorous and efficient manner, and that the resulting data are valid and
meaningful.
Some of the key applications of biostatistics in pharmaceutical product
development include:
• Study Design: Biostatisticians work closely with clinical researchers
to design clinical trials that are well-powered and well-controlled.
They use statistical methods to determine the sample size needed to
achieve the desired level of statistical power, and to allocate subjects
to treatment groups in a way that ensures balance and minimizes bias

• Data Management: Biostatisticians are responsible for developing and
implementing data management plans to ensure the accuracy, completeness, and
consistency of data collected during clinical trials. They develop data collection
forms, implement data validation checks, and oversee data entry and cleaning
procedures.
• Statistical Analysis: Biostatisticians are responsible for analyzing the data
collected during clinical trials using appropriate statistical methods. They
develop statistical analysis plans, perform statistical analyses, and interpret the
results of those analyses. They also generate tables, graphs, and other summaries
of the data for use in reports and regulatory submissions.
• Regulatory Submissions: Biostatisticians play a key role in preparing
regulatory submissions, such as new drug applications (NDAs) and biologic
license applications (BLAs). They are responsible for preparing statistical
sections of the submission, including summaries of the study results, analyses of
safety and efficacy, and descriptions of the statistical methods used in the study.
Overall, biostatistics is a critical component of pharmaceutical product
development, helping to ensure that clinical trials are well-designed, efficiently
conducted, and that the resulting data are valid and meaningful.

Data Presentation for FDA Submission
When submitting data to the FDA as part of a regulatory submission, it is
important to present the data in a clear, concise, and well-organized manner. The
following are some key considerations when presenting data for FDA submission:
1. Organize the data: Organize the data in a logical and consistent manner, using
tables, figures, and other visual aids as appropriate. Group related data together
and use clear headings and labels to make the data easy to understand.
2. Follow FDA guidelines: Follow FDA guidelines for data presentation,
including guidelines on the format and style of tables and figures. Use standard
abbreviations and avoid using non-standard symbols or graphics.
3. Use clear and concise language: Use clear and concise language to describe
the data and the results of the study. Use plain language wherever possible and
avoid technical jargon or abbreviations that may be unfamiliar to FDA reviewers.

4. Present data in context: Present the data in the context of the study design and
the study objectives. Provide a clear and concise summary of the study methods,
including the study population, treatment groups, and outcome measures.
5. Highlight key findings: Highlight the key findings of the study, including
statistically significant results and clinically meaningful differences between
treatment groups. Use tables and figures to highlight these findings and to provide
visual representations of the data.
6. Be transparent and accurate: Be transparent and accurate in the presentation
of the data. Provide clear descriptions of any statistical methods used in the
analysis, and provide appropriate caveats and limitations to the data.
Overall, the goal of presenting data for FDA submission is to provide a clear and
accurate representation of the study results in a way that is easy for FDA
reviewers to understand and evaluate. By following these guidelines, sponsors can
increase the likelihood of a successful regulatory submission and expedite the
approval process.

Management of Clinical Studies
The management of clinical studies involves a range of activities that are designed
to ensure that the study is conducted in compliance with regulatory requirements,
scientific standards, and ethical principles. The following are some of the key
aspects of clinical study management:
1. Study Planning: The first step in clinical study management is to develop a
study plan that outlines the study objectives, study design, study population,
inclusion and exclusion criteria, and outcome measures. The study plan should
also address issues such as study logistics, data management, and safety
monitoring.
2. Protocol Development: The study protocol is a detailed document that outlines
the study procedures and methods. It includes information on the study design,
study population, study procedures, and data analysis plan. The protocol should be
developed in accordance with regulatory guidelines and scientific standards, and
should be reviewed and approved by an Institutional Review Board (IRB) or
Ethics Committee.

4. Study Conduct: The study conduct phase involves the recruitment and enrollment of
study participants, the administration of study procedures, and the collection of study
data. The study should be conducted in accordance with the study protocol, and all study
procedures should be documented and monitored for compliance.
5. Data Management: The management of study data involves the collection, storage,
and analysis of study data. Data management activities should be conducted in
accordance with regulatory requirements and scientific standards, and should be
documented and monitored for accuracy and completeness.
6. Safety Monitoring: Safety monitoring is a critical aspect of clinical study
management, and involves the monitoring and reporting of adverse events and serious
adverse events. Safety monitoring activities should be conducted in accordance with
regulatory requirements and should be documented and reported to regulatory
authorities.
7. Study Close-out: The study close-out phase involves the completion of all study
activities, the finalization of study data and analysis, and the preparation of study
reports. The study close-out activities should be conducted in accordance with regulatory
requirements and scientific standards, and should be documented for future reference.

Central Drug Standard Control Organization (CDSCO)
• The Central Drugs Standard Control Organization (CDSCO) is the national regulatory
authority for pharmaceuticals and medical devices in India. It is responsible for
regulating the quality, safety, and efficacy of drugs and medical devices in the country.
• The CDSCO is part of the Ministry of Health and Family Welfare and operates under
the provisions of the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics
Rules, 1945.
• Its main functions include:
1. Approval of new drugs and clinical trials: The CDSCO is responsible for the
approval of new drugs and medical devices in India. It also regulates and monitors
clinical trials conducted in the country.
2. Registration of imported drugs and medical devices: The CDSCO also regulates
the registration of imported drugs and medical devices in India.
3. Licensing of drug manufacturing units: The CDSCO is responsible for the
licensing of drug manufacturing units in India, and monitors compliance with Good
Manufacturing Practices (GMP).

4. Post-market surveillance: The CDSCO monitors the safety and efficacy of
drugs and medical devices in the market through post-market surveillance
activities.
5. Adverse event reporting: The CDSCO requires pharmaceutical companies to
report adverse events associated with their products, and takes appropriate action
to protect public health.
Overall, the CDSCO plays a critical role in ensuring the quality, safety, and
efficacy of drugs and medical devices in India. Its regulatory functions are
essential for protecting public health and promoting the development of the
pharmaceutical industry in the country.

Organization
chart
HEADQUATAR
ZONAL
OFFICE(6)
SUBZONAL
OFFICE(3)
PORT/AIRPORT
OFFICE(7)
LABORATIES(6)
-New drugs -GMP -GMP AUDIT -IMPORT -Testing of drug samples
-Imports -coordination -coordination -Export -Validation of test product
with states with states
-DTAB/DCC
ORGANIZATION CHART OF CDSCO
Zonal offices :
Mumbai,Kolkata,Chennai,Ghaz
aibad,
Ahmdabad,Hydrabad
Sub zonal offices : Chandigarh,
Jammu, Bangalore.

State Licensing Authority
In India, the State Licensing Authority (SLA) is a regulatory body responsible for the
licensing of drug manufacturing units and drug retail shops at the state level. The SLA
is appointed by the state government and operates under the provisions of the Drugs
and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945.
The key functions of the SLA include:
1. Granting of licenses: The SLA is responsible for granting licenses to drug
manufacturing units and drug retail shops in the state, after ensuring compliance with
Good Manufacturing Practices (GMP) and other regulatory requirements.
2. Monitoring of compliance: The SLA conducts regular inspections of drug
manufacturing units and drug retail shops to ensure compliance with regulatory
requirements. It also takes action against non-compliant units and shops.
3. Suspension and cancellation of licenses: The SLA has the authority to suspend or
cancel licenses of drug manufacturing units and drug retail shops in case of non-
compliance with regulatory requirements or violation of laws.

4. Enforcement of regulations: The SLA enforces the various provisions of
the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945,
to ensure the quality, safety, and efficacy of drugs and medical devices in the
state.
5. Adverse event reporting: The SLA requires pharmaceutical companies and
drug retail shops to report adverse events associated with their products, and
takes appropriate action to protect public health.
Overall, the State Licensing Authority plays a crucial role in regulating the
pharmaceutical industry at the state level in India. Its regulatory functions are
essential for ensuring the quality, safety, and efficacy of drugs and medical
devices, and for protecting public health.

Organization chart of State Licensing Authority
State Drug
Control
Organization
Drugs
Controller
Commissioners
Deputy drug
controller
Drug Testing
Laboratory
Government
Analyst
Drug inspector
Supporting
Staff
Supporting
Staff
Analyst

Certificate of Pharmaceutical Products (COPP)
• A Certificate of Pharmaceutical Product (COPP) is a document issued by the
regulatory authority of a country to the manufacturer of a pharmaceutical product,
certifying that the product has been authorized for sale in that country and meets the
requirements of the regulatory authority.
• The COPP serves as evidence that a pharmaceutical product is authorized for sale in
a specific country and has undergone regulatory review and approval. It is also used
as part of the process for obtaining marketing authorization in other countries, as it
provides information on the regulatory status of the product in the country where it
is manufactured.
• The information contained in a COPP typically includes details such as the name
and strength of the product, the manufacturer's name and address, the manufacturing
process, and the marketing authorization status in the issuing country. The document
is usually required by regulatory authorities in other countries as part of the
registration process for the product.
• In India, the Central Drugs Standard Control Organization (CDSCO) issues the
COPP for pharmaceutical products manufactured in the country. The COPP is a
mandatory requirement for the export of pharmaceutical products from India to
other countries.

Regulatory requirements and approval procedure for new drugs
The regulatory requirements and approval procedure for new drugs vary depending on
the country or region in which the drug is intended to be marketed. However, in
general, the regulatory approval process for new drugs typically involves the
following stages:
1. Nonclinical Studies: Nonclinical studies, including pharmacology and toxicology
studies, are conducted to evaluate the safety and efficacy of the drug in animal
models. These studies are conducted to identify any potential safety concerns and to
determine the appropriate starting dose for human clinical trials.
2. Investigational New Drug (IND) Application: An IND application is submitted to
the regulatory authority, such as the US FDA, to request permission to conduct human
clinical trials of the new drug. The application includes data from the nonclinical
studies, as well as information on the proposed clinical trial design and safety
monitoring plan.
3. Clinical Trials: Clinical trials are conducted in humans to evaluate the safety and
efficacy of the new drug. These trials typically involve three phases, with each phase
designed to answer specific questions about the safety and efficacy of the drug.

4. New Drug Application (NDA) or Biologics License Application (BLA):
Once the clinical trials are complete, the results are submitted to the regulatory
authority as part of an NDA or BLA, depending on the type of drug being
developed. The NDA or BLA includes data from the nonclinical studies and
clinical trials, as well as information on the drug's manufacturing, labeling, and
proposed use.
5. Regulatory Review: The regulatory authority reviews the NDA or BLA and
makes a decision on whether to approve the drug for marketing. The review
process typically involves a team of experts who evaluate the safety and
efficacy data, as well as the manufacturing and labeling information.
6. Post-Marketing Surveillance: After the drug is approved, post-marketing
surveillance is conducted to monitor the safety and efficacy of the drug in real-
world use. This includes ongoing monitoring of adverse events and the
collection of additional data on the drug's safety and efficacy.

Regulatory affairs, Regulatory requirements for drug approval.pptx

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