GOOD REGULATORY PRACTICES in the PHARMACEUTICAL INDUSTRY

Leonila M. Ocampo, RPh, M.S.President, PPhA

14th

Biennial Convention, PAPPI

November 8, 2013

The Philippine Pharmacists Association, Inc.

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OUTLINE of the PRESENTATION

• Introduction and Objective

• Good Regulatory Practices defined

• The Code of GRP

• Essential Elements of GRP

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Introduction

Medication management is the monitoring of

medications that a patient takes to confirm that he or she is complying with a medication regimen, while also ensuring the patient is avoiding potentially dangerous drug, drug interactions and other complications.

Need : Safe, Effective and Quality Drug

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Introduction . . .

The Pharmaceutical Industry entrusted to develop, market and provide drugs to the public extends their role to promoting initiatives that will help patients access not only quality drugs and medicines but also the relevant information about them.

While regulation may not be the end and all, it is important to ensure drug quality from development until their use.

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Objective of the Presentation

• To understand Good Regulatory Practices and how it ensures the supply and availability of quality drugs and medicines and in the quality use of the medicines (QUM).

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What is Good Regulatory Practice?

Good Regulatory Practice (GRP) is defined as a quality system to ensure that the users of medicinal products, the applicants, the regulators are satisfied with the scientific advice, opinions, the establishment of maximum residue levels, inspection and assessment reports and related documents, taking into consideration legal requirements and guidance in order to protect and promote human and animal health (M. Korteweg, EMEA).

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Good Regulatory Practices

• Part of the Total Quality Management (TQM) Policy ;

> Quality system

> Quality assurance

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The Code of Good Regulatory Practice

This code of practice can be used to develop effective regulations in the following areas:

• Efficiency

• Effectiveness

• Transparency

• Clarity

• Equity

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EFFICIENCY

Adopt and maintain only regulations for which the costs on society are justified by the benefits to society, and that it achieves the objectives at the lowest cost, taking into account alternative approaches to regulation.

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EFFICIENCY GUIDELINES

• Consideration of alternatives to regulation: Regulatory design should identify and assess the most feasible regulatory and non-regulatory alternative(s) to address the problem.

• Minimum necessary regulation: When government intervention is desirable, regulatory measures should be minimal, and the least distorting, to achieve desired outcomes.

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EFFICIENCY GUIDELINES

• Regulatory benefits outweigh costs: In general, select and implement proposals with the greatest net benefit to society.

• Reasonable compliance cost: The compliance burden imposed on society by regulation should be reasonable and fair compared to the expected regulatory benefit

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EFFICIENCY GUIDELINES

• Minimal fiscal impact: Regulators should develop regulatory measures that minimize the financial impact of administration and enforcement

• Minimal adverse impact on competition: Regulation should have a minimal negative impact on competition.

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EFFICIENCY GUIDELINES

• International compatibility: Where appropriate, regulatory measures or standards should be compatible with relevant international or internationally accepted standards or practices to maximize the benefits of trade.

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EFFECTIVENESS

Regulation should be designed to achieve the desired policy outcome.

Effectiveness guidelines:

• Reasonable compliance rate: A regulation is neither efficient nor effective if it is not complied with or cannot be effectively enforced. Regulatory measures should contain compliance strategies that ensure the greatest degree of compliance at the lowest possible cost to all parties. Incentive effects should be made explicit in any regulatory proposal.

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EFFECTIVENESS GUIDELINES

> Compatibility with the general body of law, including the statute which it amends, statutes which apply to it, and the general body of the law of statutory interpretation.

> Compliance with basic principles of our legal and constitutional system.

• Flexibility of regulation and standards: Regulatory measures should be able to be revised, adjusted and updated as circumstances change

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EFFECTIVENESS GUIDELINES

> Performance-based requirements that specify outcomes rather than inputs should be used, unless prescriptive requirements are unavoidable. This helps ensure predictability of regulatory outcomes and facilitate innovation.

> Review regulations systematically to ensure they continue to meet their intended objectives efficiently and effectively.

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TRANSPARENCY

The regulation making process should be transparent to both the decision-makers and those affected by regulation.

Transparency guidelines:• Problem adequately defined: Identifying the

nature and extent of the problem is a key step in the process of evaluating the need for government action. Properly done, problem definition will itself suggest potential solutions and eliminate others that are clearly not suitable.

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TRANSPARENCY GUIDELINES

• Clear identification of the objective of regulation: The policy goal should be clearly specified against the problem and have a clear link to government policy.

• Cost benefit analysis: Regulatory proposals should be subject to a systematic review of the costs and benefit. Resources invested in cost benefit estimation should increase as the potential impact of the regulation increases.

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TRANSPARENCY GUIDELINES

• Risk assessment: Regulatory proposals should be subject to a risk assessment, which should be as detailed as is appropriate in the circumstances.

• Direct approaches to a problem: In general, adopting a direct approach aimed at the root cause of an identified problem ensures that a more effective and efficient outcome is achieved, compared to an indirect response

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TRANSPARENCY GUIDELINES

• Public consultation should occur as widely as possible, given the circumstances, in the policy development process. A well-designed and implemented consultation program can contribute to better quality regulations; identification of the more effective alternatives; lower costs to business and administration; ensure better compliance; and promote faster regulatory responses to changing conditions.

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CLARITY

Regulatory processes and requirements should be as understandable and accessible as practicable.

Clarity guidelines:

• Make things as simple as possible while still achieving the regulatory objective.

• Plain language drafting: Where possible, regulatory instruments should be drafted in plain language to improve clarity and simplicity, reduce uncertainty, and to enable those affected to better understand the implications of regulatory measures.

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CLARITY GUIDELINES

• Discretion should be kept to a minimum, but be consistent with the need for the system to be fair. Good regulation should attempt to both minimize and standardize the exercise of bureaucratic discretion to reduce discrepancies between government regulators, reduce uncertainty, and lower compliance costs.

• Educating the public as to their regulatory obligations is fundamental in ensuring compliance.

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EQUITY

Regulation should be fair and treat those affected equitably.

Equity guidelines:

• Obligations, standards, and sanctions should be designed so they can be imposed impartially and consistently.

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EQUITY GUIDELINES

• People in like situations should be treated in a similar manner. Similarly, people in disparate positions may be treated differently.

• Reliance should be able to be placed on processes and procedures of the regulatory system: A regulatory system is regarded as fair or equitable when individuals agree on the rules of that system, and any outcome of the system is considered just.

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Essential Elements of GRP

• be flexible

• use risk management principles

• be consistent in guidance and decision-making

• be efficient in information and records management

• measure and maintain performance and transparency

• be reachable and reach out to stakeholders

• be aware of changing regional and global factors in

R&D and access to drugs

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FLEXIBILITY OF REGULATIONS

Regulations should:

• Cover principles broadly

• Provide sufficient protection to the public

• Strike a balance between protection of the

public and enabling R&D

• Be forward-looking, allowing flexibility for

regulating in the current and future

environment

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USE RISK MANAGEMENT PRINCIPLES

Precautionary principle: “absence of full scientific certainty shall not be used as a reason to postpone decisions when faced with the threat of serious or irreversible harm”

• Proactive – take initiative to address public health & safety concerns

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USE RISK MANAGEMENT PRINCIPLES

• Know own strengths and weaknesses:

> Consult with experts on complex scientific, medical, or regulatory issues

> Implement and make use of scientific advisory committees

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CONSISTENCY in GUIDANCE and DECISION-MAKING

• Adopt international guidelines when appropriate

• Develop SOPs:

> Good guidance practices

> Good review practices

• Develop and implement guidelines to address

regional issues

• Be aware of drivers, such as globalization

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EFFICIENCY in INFORMATION and RECORDS MANAGEMENT• Develop and implement tools to manage

documentsand information submitted by sponsors

> Maintain accurate records with a numbering system for sponsor/drug and submissions

> Clinical trial applications, amendments and notifications

> ADR database for integration and analysis> Submission allocation database> Clinical trial inspection database

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EFFICIENCY in INFORMATION and RECORDS MANAGEMENT

• System to manage other information such as general inquiries

• Ensure security and maintain confidentiality of records

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MEASURE and MAINTAIN PERFORMANCE and TRANSPARENCY

• Measure workload and performance at periodicintervals (e.g., quarterly)

• Use information on workload and performanceto develop/revise business plans

• Publish performance measures periodically( e.g., annually)> Number of clinical trials, protocol

amendments, notifications, ADRs, types of trials, etc.

> Submission processing and review times

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Be Reachable and Reach Out toStakeholders

• Provide opportunities for dialogue with sponsors and stakeholders formally and informally (e.g., pre-clinical trial meetings, telephone conferencing, informal email

inquiries)

• Provide for appeal processes and opportunities for reconsideration of final decisions

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Be Reachable and Reach Out toStakeholders

• Consult with all stakeholders before implementing or adopting new regulations, policies, and guidelines

• Consult with stakeholders as early as possible

• Communicate horizontally within organization

• Seek lessons learned through impact analysis

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Impact on R&D: Regional Factors

• Analyze regional factors:

> Population (e.g., demographics, diseaseprevalence)

> Health care system and infrastructure

> Available expertise

> National support in research funding

> Regulatory frameworks for importation and sale of drugs

> Geographic location and neighboring countries

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Impact on R&D: Global Factors

• Be aware of, and prepare for, global impact & trends:

> Multinational clinical trials

> Harmonization

> Decreased number of blockbuster drugs

& exponential rise in generics

> Personalized medicine, pharmacogenomics

> Rising costs and emerging markets

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Impact on R&D: Global Factors

> In choosing to place a clinical trial, companies will look for countries with the appropriate laws, along with the required population, disease prevalence, health care system, qualified investigators and staff, with high standards of professional integrity and ethics

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In closing,

.

Marketing of pharmaceutical products should be regulated so as to ensure not only the safety, but the efficacy of the product and most importantly;

the safety and optimum health outcomes of the Patients.

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In closing,

Drug regulation is needed to promote health!

Thank you for your attention