Regulatory Guidelines for Registration and Submission Criteria in South Africa (SAHPRA)

Fachbuch , 2022 , 100 Seiten

Pharmazie

This publication examines the regulatory guidelines for registration and submission criteria in South Africa. South African Health Products Regulatory Authority (SAHPRA) is the entity of the national department of health (NDoH) launched in February 2017. It replaced the former Medicines Control Council (MCC) as well as Directorate of Radiation Control (DRC) that regulated medical devices in-vitro diagnostic tests and devices, radiation-emitting products and devices used in health care and industry.

Due to several drawbacks of MCC such as becoming dependent on external expertise, it eventually lead to lack of effective performance management contracts and unsustainable mechanism for submission of evaluation reports, SAHPRA is established. An application for registration of medicines should be submitted for evaluation and approval through SAHPRA guidelines which are applicable to human medicines including biological and complimentary medicines.

So SAHPRA adopted EU variation guidelines for quality and bio equivalence requirements for new registration and variations that are submitted by applicant in eCTD format established by the International Council for Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. Submission of applications are done by following South Africa eCTD validation criteria in module 1 of regional information provided by South Africa.

LIST OF CHAPTERS

I INTRODUCTION

II GENERAL INFORMATION

III EUROPEAN UNION VARIATION GUIDELINES

IV REGISTRATION REQUIREMENTS

V e-CTD VALIDATION CRITERIA

VI SUBMISSION OF REGULATORY INFORMATION IN e-CTD FORMAT

VII DOCUMENTATION

VIII CONCLUSION

BIBLIOGRAPHY

ACKNOWLEDGEMENT

I would like to express my special thanks of heartfelt gratitude to my guide Dr. P. SHAILAJA, Department of Pharmaceutical Technology, Andhra University College of Pharmaceutical Sciences, Andhra University, for her vital support, relentless motivation, encouragement and a valuable guidance throughout my course.

I take this opportunity to extend my gratitude to Prof. Y. Rajendra Prasad, Principal, Andhra University College of Pharmaceutical Sciences, Andhra University, for encouraging me to carry out my project work.

I also express my gratitude to Prof. J. Vijaya Ratna for her valuable suggestions and encouragement during this course of my study.

I express my sincere thanks to G. Sneha Latha our scholar for her guidance during my project work.

I owe my special thanks to my senior M. Siva Shankar for his continuous support in completion of my thesis.

I also express my special thanks to my friends Ch. Sreya, V. Mani Deepa, P. Bhagyalakshmi, B. Guna Sree, G. Shailaja, K. Pragna, T. Baby Padmini, D. Nikhila Pallavi for their encouragement and help during my project work.

I owe my thanks to all my seniors and juniors for providing with everything that is needed for my work.

I would like to express my deep gratitude to my beloved parents N. Srinivasa Rao and N. Geetha Devi and my brother N. Veeracharyulu for their affection and support, which has sustained me a lot in the successful completion of my project work.

I take this opportunity to sincerely thank all the people directly or indirectly involved in my project work. I would like to thank all teaching and non-teaching staff who supported me during my course completion.

Thankfully, I ever remain...

LIST OF ABBREVATIONS

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CHAPTER I: INTRODUCTION [1-9]

Background of SAHPRA: South African Health Products Regulatory Authority (SAHPRA) is an entity of the National Department of Health launched in February 2017. SAHPRA is a public entity of the National Department of Health (NDOH) that was formed by the South African government as an independent authority to oversee the regulation of health products. SAHPRA replaced the former Medicines Control Council (MCC), as well as the Directorate of Radiation Control (DRC) that regulated medicines, medical devices, in vitro diagnostic tests and devices, and radiation-emitting products and devices used in health care and industry. SAHPRA was established by the Medicines and Related Substances Amendment Act of 2008 and 2015.

HISTORY:

The MCC and DRC were national authorities in South Africa that regulated medicines and medical devices before the establishment of SAHPRA. These agencies were responsible for regulating, assessing, registering, inspecting, and controlling medicines, medical devices, clinical trials, scheduled substances, and associated matters in the interest of public health. The legislative responsibilities of these authorities were to make certain the required standards of quality, safety, and efficacy of medicines and devices available in South Africa were met.

THE MEDICINES CONTROL COUNCIL:

Before the establishment of SAHPRA in February 2018 the MCC was the national medicines regulatory authority of South Africa responsible in terms of the Act to provide for the monitoring, evaluation, regulation, investigation, inspection, registration, and control of human and veterinary medicines, scheduled substances, clinical trials and related matters in the public interest. The statutory obligations of the MCC were to ensure that medicines that were available in South Africa met the required standards of quality, safety, and efficacy.

Organization:

The MCC was a statutory body appointed by the Minister of Health consisting of not more than 24 members including the chairs of the expert committees. In addition, the council appointed external experts to serve on various expert committees overseeing medicine registration, regulation, and control functions. Overall there were 11 active expert committees including the Biological Medicines, Clinical, Clinical Trials, Complementary Medicines, Legal, Medical Devices, Names & Scheduling, Pharmaceutical & Analytical, Pharmacovigilance, and Veterinary Clinical Committees.

The Office of the Registrar served as the Executive Secretary to the MCC and provided administrative and technical support to Council and its activities. The Office of the Registrar was a Chief Directorate within the National Department of Health known as the Cluster: Food Control, Pharmaceutical Trade and Product Regulation. There were four Directorates within the Cluster: Operations, and Administration, Inspectorate and Law Enforcement, Medicines Evaluation and Research, and Clinical Evaluation and Trials. The staff complement of the Cluster included doctors, pharmacists, veterinarians, scientists, and administrative staff.

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Organizational Structure of the MCC

Regulatory Review Process:

The registration of medicines in South Africa is governed by the provisions and requirements of the Medicines Act including the regulations and the published guidelines. Legislative frameworks require that medicines including New Chemical Entities, multisource/generic medicines, biological medicines, complementary medicines, and veterinary medicines are evaluated by the NRA before marketing the product. Applicants are required to submit technical dossiers to demonstrate the quality, safety, and efficacy of such medicines intended for sale in South Africa. The confidentiality of information submitted to the NRA is governed by Section 34 of the Medicines Act regarding the preservation of secrecy. The NRA made use of both internal and external expertise to evaluate applications for the registration of medicines. A full review of the safety, quality, and efficacy data, together with the assessment reports prepared by reviewers were considered by the various expert committees to make recommendations on the approval of the proprietary name of the product, the allocation of a scheduling status for the active pharmaceutical ingredient and the evaluation of the GMP status of the applicant, the manufacturer of the active pharmaceutical ingredient, the manufacturer of the finished pharmaceutical product, the packer and the quality control laboratory. The final decision for authorization or refusal was made by the MCC.

THE SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA):

The South African Health Products Authority (SAHPRA) is the Regulatory Authority of South Africa, which is responsible for the regulation of health products intended for human and animal use; the licensing of manufacturers, wholesalers and distributors of medicines, medical devices, radiation emitting devices and radioactive nuclides; and the conduct of clinical trials which is an extended mandate to the past MCC which only deals with regulatory oversight of human, and veterinary medicines.

In February 2017 SAHPRA was legally established as a Schedule 3A Public Entity. As a Schedule 3A Public Entity SAHPRA is a separate juristic person outside of the National Department of Health accountable for sound corporate governance practices, and adherence to compliance codes in terms of relevant legislation, financial regulations, directives, policies, and procedures.

Organization:

In October 2017 the Minister of Health, Aaron Motsoaledi, announced the appointment of 15 SAHPRA Board members. The Board members are appointed to serve for a period of 3 years under the leadership of Professor Helen Rees, the outgoing Chairperson of the MCC and the first Chairperson of the SAHPRA Board. In contrast to the MCC the, SAHPRA Board has full operational autonomy and accountability. Through the Board the Authority is accountable to the Minister of Health. The SAHPRA Board after consultation with the Minister of Health must appoint a suitably qualified person as the CEO of the Authority. The CEO is accountable to and reports to the SAHPRA Board and is responsible for the general administration of the Authority and the carrying out of any functions assigned to the Authority.

The four Directorates will be replaced by five programs responsible for performing the regulatory activities of the Authority. A Regulatory Advisory/Oversight Committee for medicines and medical devices has been appointed by the CEO in consultation with the SAHPRA Board to investigate and report to the Authority on any matter within its purview in terms of Medicines and Related Substances Act, 1965 (Act 101 of 1965).

The SAHPRA Board may appoint one or more committees from among its members to assist it with the performance of its functions and has appointed a committee to investigation into the backlog in an application for registrations as part of its responsibility.

Transitional Organization Structure of the SAHPRA

PRIMARY ACTIVITIES OF SAHPRA:

All health goods must be regulated by SAHPRA, which is responsible for monitoring, evaluating, investigating, inspecting and registering them. This includes clinical trials, complementary medicines, medical devices and in vitro diagnostics (IVDs). The additional duty of managing radiation control in South Africa lies under SAHPRA. SAHPRA’s directive is outlined in the Medicines and Related Substances Act (Act No 101 of 1965 as amended) as well as the Hazardous Substances Act (Act No 15 of 1973). To ensure that drugs, medical devices, and IVDs follow the requirements necessary to safeguard South Africans' health and well-being, SAHPRA has three pillars that make up the SAHPRA philosophy. They are,

1. Safety
2. Quality
3. Efficacy

It helps to promote Access to health products and protect human and animal health in South Africa through making science-based regulatory decisions.

SAHPRA Directive Responsibilities and Functions:

The legislative mandate of SAHPRA is derived from the Constitution of the Republic of South Africa, 1996 which places obligations on the state to progressively realize socio-economic rights including access to health care as well as the National Health Act, 2003 (Act 61) and the Medicines and Related Substances Act, 1965 (Act 101 of 1965). According to the Medicines and Related Substances Act, 1965 (Act 101 of 1965), “SAHPRA’s obligations include ensuring public protection, ensuring transparency and accountability in its operations and being responsive to the regulatory environment.”

The functions of the Authority are defined in Section 2B of the Medicines and Related Substances Act, 1965 (Act 101 of 1965). The Authority must, to achieve its objectives, ensure that the:

1. “Evaluation or assessment and registration of medicines and medical devices, is efficient, effective, and ethical, and that registered medical products meet the defined standards of quality, safety, efficacy, and performance;
2. Process of evaluating or assessing, and registering medicines, and medical devices is transparent, fair, objective and concluded timeously;
3. Medicines and medical devices are re-evaluated or reassessed and monitored periodically;
4. Existing and new adverse events, interactions and information about post-marketing surveillance and vigilance are monitored, analyzed and acted upon; Compliance with existing legislation is being promoted and controlled through a process of active inspection and investigation; and
5. Clinical trial protocols are assessed according to prescribed ethical and professional criteria and defined standards”

The key operational differences between the MCC and SAHPRA are mentioned in the following table. The mandate of SAHPRA has been extended to include medical devices and complementary medicines and the legislative framework for reliance and recognition has been finalized. It is anticipated that improvements to the other operational elements listed in the table will be realized with the establishment of SAHPRA.

Key operational differences between the MCC and SAHPRA:

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Challenges and Changes:

Historically the MCC faced resource constraints as workloads placed on the regulator steadily increased. As a result, the MCC became dependent on over-committed external expertise. Evaluation structures that relied on external evaluators lacked effective performance management contracts and did not provide a sustainable mechanism for timely the submission of evaluation reports. The regulatory functions mandated by SAHPRA are people-dependent. Adequate, competent, and motivated human capital plays a vital role in ensuring organizational success. “It is the intended goal of SAHPRA to have an adequate number of staff with the right skills mix, at the right level, available and employed in appropriate positions within the organization.” Efforts to reform organizational structures within SAHPRA should be prioritized to build and retain in-house scientific skills to decrease over-reliance on external expertise.

The declaration of the recently amended Medicines and Related Substance Act, 1965 (Act 101 of 1965) hereafter referred to as the Medicines Act generated the establishment of the SAHPRA as a separate juristic person outside of the National Department of Health to replace the former medicine regulatory authority the MCC. The amended Medicines Act saw the scope of the Authority’s mandate extended to make provision for the regulatory oversight of medical devices and complementary medicines in South Africa and to make provision for the Authority to establish and strengthen collaborative initiatives with any other regulatory authorities or institutions.

The following chapters mainly deal with the guidelines of human medicines and complementary medicines along with their submission criteria.

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• Hochschule: Andhra University (A. U. College of Pharmaceutical Sciences, Andhra University, Visakhapatnam)
• Veranstaltung: Pharmaceutical Regulatory Affairs
• Autoren: Dr Shailaja Pashikanti (Autor:in), G. Snehalatha (Autor:in), N. S. R. L. Manimala (Autor:in)
• Erscheinungsjahr: 2022
• Seiten: 100
• Katalognummer: V1304787
• ISBN (PDF): 9783346777867
• ISBN (Buch): 9783346777874
• Sprache: Englisch
• Schlagworte: Regulatory, guidelines, Registration, submission, South Africa, SAHPRA