Regulatory compliance is a crucial aspect of conducting clinical research, ensuring that studies meet the requirements and standards set by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and other relevant bodies. Here are some key points to navigate regulatory compliance in clinical research: Familiarize Yourself with Applicable Regulations: Stay updated on the relevant regulations and guidelines that govern clinical research, including FDA regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, and local regulatory requirements. Understand the specific regulations that apply to your study, such as those related to investigational new drugs (IND) or investigational device exemptions (IDE). Obtain Institutional Review Board (IRB) Approval: IRBs play a crucial role in ensuring the protection of human subjects in research. Before initiating a clinical trial, obtain IRB approval by submitting a detailed study protocol, informed consent documents, and other required materials. IRBs review the study's scientific merit, ethical considerations, and compliance with regulations. Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application: If your clinical research involves the use of investigational drugs or devices, you may need to submit an IND or IDE application to the FDA. These applications provide detailed information on the investigational product, its safety, efficacy, manufacturing processes, and proposed study design. Good Clinical Practice (GCP) Guidelines: GCP guidelines provide a framework for the conduct of clinical research to ensure data integrity and participant protection. Adhere to GCP principles, including informed consent, protocol adherence, accurate documentation, and appropriate monitoring and reporting of adverse events. Adverse Event Reporting: Monitor and report adverse events occurring during the study promptly. Follow the FDA's requirements for safety reporting, including expedited reporting of serious and unexpected adverse events. Maintain accurate and complete records of adverse events and their follow-up actions. Data Integrity and Documentation: Ensure the integrity, accuracy, and traceability of study data. Implement robust data management practices, including proper documentation, source data verification, and secure storage of study documents. Follow regulatory requirements for data retention, including archiving study records for the required period. Audits and Inspections: Be prepared for audits and inspections by regulatory agencies. Maintain organized and easily accessible study documentation, including study protocols, informed consent forms, case report forms, and correspondence with IRBs and regulatory agencies. Cooperate with auditors or inspectors and address any identified deficiencies or findings promptly.

1. Welcome
REGULATORY COMPLIANCE IN CLINICAL
RESEARCH: NAVIGATING THE FDA AND OTHER
AGENCIES
10/18/2022 WWW.CLINOSOL.COM | FOLLOW US ON SOCIAL MEDIA @CLINOSOLRESEARCH 1
Student Name: Gokani pooja goud
Qualification: Pharm. D
Student ID: 064/042023

2. 10/18/2022 WWW.CLINOSOL.COM | FOLLOW US ON SOCIAL MEDIA @CLINOSOLRESEARCH 2
CLINICAL RESEARCH
REGULATORY COMPLIANCE
OVER VIEW OF FDA
FDA REGULATIONS IN CLINICAL RESEARCH
FDA’S CGMPS
OTHER REGULATORY AGENCIES
SCOPE OF SUCH ORGANISATIONS
CHALLENGES
CONCLUSION
REFERENCES
INDEX

3. 3
Clinical research is a branch of healthcare science that determines the safety and effectiveness
(efficacy) of medications, devices, diagnostic products, and treatment regimens intended for
human use. These may be used for prevention, treatment, diagnosis, or for relieving symptoms
of a disease. Clinical research is different from clinical practice. In clinical practice, established
treatments are used, while in clinical research evidence is collected to establish a treatment.
Clinical research ethics are the set of relevant ethics considered in the conduct of a clinical
trial in the field of clinical research. It borrows from the broader fields of research
ethics and medical ethics.
REGULATORY COMPLIANCE
Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to
ensure that they are aware of and take steps to comply with relevant laws, policies,
and regulations. The adherence to laws, regulations, and guidelines created by government
legislations and regulatory bodies applicable to an organization based on the industry and
jurisdiction in which it operates.
CLINICAL RESEARCH

4. OVERVIEW OF FDA
FOOD AND DRUG ADMINISTRATION (US)
Food and Drug Administration(FDA), a federal agency of the united states department of Health and
human services was formed in June 1906. FDA headquarters facilities are currently located
in Montgomery County and Prince George's County, Maryland.
The Food and Drug Administration (FDA) is responsible for advancing public health by helping to speed
innovations that make medicines safer and more effective and by helping the public get the accurate,
science-based information it needs to use medicines to maintain and improve public health.
Protecting the rights, safety, and welfare of people who participate in clinical trials is a critical aspect of
the FDA’s mission. FDA oversees clinical trials to ensure they are designed, conducted, analyzed, and
reported according to federal law and good clinical practice (GCP) regulations.
 FDA’s regulations and guidance for clinical trials help support efficient medical product development
while assuring trials generate the robust evidence needed to assess product safety and efficacy. The
agency works to ensure its GCP policies continue to facilitate new approaches to generating quality
clinical evidence.
10/18/2022 WWW.CLINOSOL.COM | FOLLOW US ON SOCIAL MEDIA @CLINOSOLRESEARCH 4

5. 5
FDA REGULATIONS IN CLINICAL RESEARCH
GOOD CLINICAL PRACTICE (GCP)
 FDA regulations for Good Clinical Practices (GCPs) can be found in 21 CFR 312.
 FDA has published a consolidated guideline for GCP in conjunction with the ICH guideline (E6, 62
Fed. Reg. 25692, 1998).
 The consolidated guideline for GCP aims to provide a unified standard for conducting clinical studies
and applies to all aspects of clinical trials.
 The standards cover protocol design, monitoring, auditing, recording, analysis, and reporting of
clinical data presented in new drug applications to the FDA.
 FDA and ICH issue guidance documents related to GCPs, as illustrated as part of the Quality System
Model.
 The overall aim of GCP is to protect public health and the rights, welfare, and confidentiality of study
participants.
 GCP ensures that all data and reported results are credible, accurate, and evidence-based, while also
emphasizing the importance of the processes used to conduct clinical trials.
 FDA embraces GCPs as a “Quality System Approach to New Drug Development and Approvals” and
focuses on the conduct of clinical trials.
 Manufacturers, sponsors, clinical investigators, and institutional review boards must comply with the
regulations and requirements of GCP while conducting clinical trials..

6. 6
The FDA’s new drug approval process begins with research plans involving basic research, laboratory,
and animal testing. This initial stage includes the discovery and development of prototypes involving
preclinical and clinical studies of new drug materials to be reviewed and approved by an institutional
review board (IRB). These IRBs exist in hospitals, university medical centers, and private clinical research
institutions at which clinical trials take place. Before a clinical trial is initiated, foreseeable risks are
weighed against the anticipated benefits for the individual trial subject and the intended clinical
population. Generally, a clinical trial is initiated and continued only if the anticipated benefits are feasible.
The FDA filing and premarket applications consist of the following categories:
1. Investigational New Drug Application (IND)
2. New Drug Application (NDA)
3. Abbreviated New Drug Application (ANDA)
For a drug manufacturer to introduce a product in the market for human use, a multiphase procedure is
followed. This procedure begins with a number of preclinical or “prior to human” testing, followed usually
by three phases of human studies.1,3,5 New drugs are also subject to a fourth phase, known as post-
market surveillance, which may require additional trial data. The FDA has published detailed information
on the drug development process (www.fda.gov/cder/handbook/develop.htm). This publication not only
addresses the importance of interactions between the sponsor and the FDA but also emphasizes the
interactions between the various stages of investigational studies and the continuing dialogue with the
FDA review status throughout the development and completion of premarket application.
PRINCIPLES AND PROCEDURES FOR NEW DRUG APPLICATIONS

7. 7
IND
 IND (Investigational New Drug) submission is made to the FDA to seek permission to initiate clinical
studies of a new drug product in the US.
 The purpose of an IND is to request an exemption from the prohibition of introducing any new drug into
interstate commerce without an approved application or to allow a firm to request permission to ship an
“unapproved drug” or import the new drug from a foreign country.
 The IND allows a company to conduct clinical studies of its investigational drug product and to gather
safety and efficacy data about the drug compound in humans.
 Meetings between the sponsor and the FDA take place during these studies.
 The requirements for the format and content of the IND application are provided in (21 CFR Part 312).

8. 8
NDA
 NDA (New Drug Application) is a premarket submission to the FDA requesting approval for marketing a
new drug in the US.
 The FDA reviews the NDA application and makes a decision on whether the drug application is fillable.
 An advisory committee meeting of outside experts is arranged by the FDA to seek their
recommendation on the approvability of the premarket application.
 The NDA submission is organized into specific technical sections, which are evaluated by specialized
FDA review teams.
 The FDA authority to require an NDA is drawn from section 505 of the Food, Drug and Cosmetic Act {21
USC 355}.
 The content and format of an NDA is laid out in 21 CFR Part 314 and guidance documents published by
FDA.
 When all the aforementioned steps are completed, the FDA inspects the manufacturing plant to ensure
the sponsor’s facilities are capable of manufacturing the drug in compliance with the FDA’s current
good manufacturing practices (cGMP) regulations.

9. 9
ANDA is for new drugs approved which must be pharmaceutically equivalent and bioequivalent to
predicate product, usually an innovator or pioneer drug (reference listed product 21CFR 314.94) ANDA is
a submission to FDA as an ANDA. These applications are called “abbreviated” because the generic drug
manufacturers are not required to include preclinical or clinical data to establish safety and effectiveness
because those characteristics were already established by the manufacturer of the innovator drug
through the NDA process. The sponsor of an ANDA must provide information and data demonstrating
that the drug product is bioequivalent to the innovator drug and that the proposed use and labeling are
identical to that of the reference innovator drug. ANDA sponsor manufacturers are subject to the same
inspection requirements that apply to manufacturers of new innovator drugs.

10. 10/18/2022 WWW.CLINOSOL.COM | FOLLOW US ON SOCIAL MEDIA @CLINOSOLRESEARCH 10
FDA APPROVAL TIME

11. 11
FDA’S GOOD MANUFACTURING PRACTICES (CGMPS)
Current Good Manufacturing Practices (cGMPs)Pharmaceutical cGMPs (Title 21 CFR 210 & 211) are the part of quality assurance practices
that ensure the drug products are consistently produced and controlled in conformance with quality standards.1 They are known as current
manufacturing practices, processing, packing, or holding of drugs and current manufacturing practices for finished pharmaceuticals. The ICH
Q10 was adopted by US in 2009. The FDA guidance, “Quality Systems Approach to Pharmaceutical CGMPs” describes the aim of theagency
to help manufacturers implementing modern quality systems and risk management tools to meet the requirements of the agency’s current
approaches to cGMPs. The implementation of ICH Q10 throughout the product life cycle facilitates and strengthens the link between drug
development and manufacturing activities. In addition to ICH Q10, the FDA adopted industry sponsored guidelines for continuous quality
improvement (ISBN 0273 -3099). The FDA appears committed to support ways to promote drug development, and is willing to
accommodate NDA sponsors to use improved quality management approaches to foster innovations and improvements. These approaches
help enhance the consistency and coordination of the FDA’s drug quality regulatory programs, in part, by further integrating enhanced
quality systems approaches into the agency’s regulatory processes concerning review and inspection activities. In reference to NDAs, cGMPs
include quality system approaches whereby the sponsor addresses the specifications of the drug product and the manufacturing process
controls from the prototype design to the production and release of the finished product . The FDA’s CGMP regulations do not prescribe in
detail how a manufacturer must proceed as it designs and manufactures a specific drug product. Instead, a framework is presented
requiring the manufacturer to develop and follow procedures and to fill in the appropriate details for a particular drug; however, the most
important point behind GMP regulations is that quality must be designed and built into a product. As development proceeds, the active
drug substance and dose form must be manufactured at larger scales. This scale-up may introduce variations in the manufacturing steps of
drug product. Thus, it is critical to monitor the drug substance and product for variations during development and manufacturing processes.
The emphasis of design controls drug GMPs should be on products that conform to defined user needs and intended uses. For NDA
applications, it is essential to have data showing that the product and active drug substance have documented stability in the packaging
that will be used for marketed product. FDA GMP regulations require information about all the steps of the manufacturing process from
incoming materials to final distribution of the product .

12. 12
The FDA’s 21st century cGMP and ICH initiatives (such as Q8 Pharmaceutical Development, Q9 Quality Risk Management,
and Q10 Pharmaceutical Quality System), evolved into new regulatory practices and procedures for NDA applications and
appovals (Figures 3 & 5). Risk management can be applicable in several areas of PV, from early process/development
through maintenance of validated stages during manufacturing processes.1-5 Some of the benefits of science- and risk-
based approaches during PV are as follows:-Benefits process understanding by proactive identification of failure modes
(hazards), and managing the identified risks as early on in the product life cycle-Enables that high risk, critical aspects of
the process are well recognized by appropriately designed studies-Monitoring of risks reduces product and process
failures.

13. 13

14. 14

15. 15

16. 10/18/2022 WWW.CLINOSOL.COM | FOLLOW US ON SOCIAL MEDIA @CLINOSOLRESEARCH 16
OTHER REGULATORY AGENCIES
MAJOR REGULATORY BODIES

17. 10/18/2022 WWW.CLINOSOL.COM | FOLLOW US ON SOCIAL MEDIA @CLINOSOLRESEARCH 17
Country Regulatory authority
USA Food and Drug Administration (FDA)
UK Medicines and Healthcare Products Regulatory Agency (MHRA)
Australia Therapeutic Goods Administration (TGA)
India Central Drug Standard Control Organization (CDSCO)
Canada Health Canada
Europe European Medicines Agency (EMEA)
Denmark Danish Medicines Agency
Costa Rica Ministry of Health
New Zealand Med safe - Medicines and Medical Devices Safety Authority
Sweden Medical Products Agency (MPA)
Netherlands Medicines Evaluation Board

18. 18
Country Regulatory authority
Ireland Irish Medicines Board
Italy Italian Pharmaceutical Agency Nigeria National Agency for Food and Drug
Administration and Control (NAFDAC)
Ukraine Ministry of Health
Singapore Centre for Pharmaceutical Administration Health Sciences Authority
China State Food and Drug Administration
Germany Federal Institute for Drugs and Medical Devices
Pakistan Drugs Control Organization, Ministry of Health
South Africa Medicines Control Council
Thailand Ministry of Public Health
Brazil Agencia Nacional de Vigiloncia Sanitaria (ANVISA )
Japan Ministry of Health, Labour & Welfare(MHLW)
Paraguay Ministry of Health
Sri Lanka SPC, Ministry of Health
Switzerland Swiss medic, Swiss Agency for Therapeutic Products

19. 19
INTERNATIONAL ORGANIZATIONS
World Health Organization (WHO)
Pan American Health Organization (PAHO)
World Trade Organization (WTO)
International Conference on Harmonization (ICH)
World Intellectual Property Organization (WIPO)
Common Scope of Such Organizations
Regulatory authorities act as a guardian that ensures the safety, efficacy and quality of drugs available to
the public, to identify the strengths and weaknesses of drug regulation and to propose strategies to
improve drug regulation. They also play a vital role to ensure and increase regulatory implementation in
non-regulated parts of the world for safety of people residing there. The international regulatory
organizations play essential role inall aspects of pharmaceutical regulations related to drug product
registration, manufacturing, distribution, price control, marketing, research and development, and
intellectual property protection.

20. 20
Challenges
The major challenges of these regulatory bodies are* To promote public health and protect the public from harmful and
dubious drugs,* To establish proper legalization covering all products with a medicinal claim and all relevant
pharmaceutical activities, whether carried out by the public or the private sector.* To increase worldwide regulatory
growth to ensure safety of people.
Conclusion
Regulatory agencies and organizations around the world need to ensure the safety, quality and efficacy of medicines and
medical devices, harmonization of legal procedures related to drug development, monitoring and ensuring compliance
with statutory obligations. However the need of the hour is more centralized procedures in drug regulation.
Harmonization of regulatory norms Strengthening the regulatory authorities.

21. 21
REFERENCES
https://en.m.wikipedia.org/wiki/Food_and_Drug_Administration
https://www.fda.gov/
https://www.pharmatutor.org/
https://drug-dev.com/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5372399/
https://www.arenasolutions.com/resources/glossary/fda-
compliance/#:~:text=FDA%20(Food%20and%20Drug%20Administration,medical%20devic
es%2C%20and%20biological%20products.

22. ThankYou!
WWW.CLINOSOL.COM
(INDIA | CANADA)
9121151622/623/624
INFO@CLINOSOL.COM
10/18/2022 WWW.CLINOSOL.COM | FOLLOW US ON SOCIAL MEDIA @CLINOSOLRESEARCH 22