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Good Review Practice – Communications- Fundamentals of Communication for Regulatory Authorities

and Experience Sharing on Interagency communication

1st Thailand GRM Conference, Bangkok, Thailand, June 26-28, 2018

Hsien-Yi Lin, PhD

Senior Reviewer, Division of Medicinal Products

Taiwan Food and Drug Administration

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Communications

Other authority

The public The applicants

External experts

Regulatory authority

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Communications

Other authority

The public The applicants

External experts

Regulatory authority

Intra‐agency

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Intra-agency communications

• Improving efficiency by:– Collaboration among scientific reviewers– Defining roles and responsibilities 

• Review team members • Leadership

– Transparency– Equal voices

• Open, clear, constructive and timely communications in:– Progress of review, sharing review findings, differing data interpretations, 

resolution mechanisms, decision makings on actions

• Establishing format and process of communications– Within agency– With external stakeholders (experts, public, RA, applicants, etc.)

Evidence‐based review and decision making are critical for accountability !

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TFDA Organization Chart

Product reviews require coordination different organizational units within the RA.  

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External Experts

Division of Medicinal Products Organization Chart

Division of Medicinal Products

Section 1 Drug Safety and EvaluationPost‐marketing monitoring, AE/AR report.

Section 2 New drugsRegistration/PAC/RMP of NCE, Bio, imported drug.

Section 3 Generic drugsRegistration/ PAC of domestic drugs.

Section 4 Regulatory Science

Section 5 Clinical Trial ManagementClinical trials protocol/report verification, GCP inspection.

Section 6 Pharmaceutical Management

Center of Drug EvaluationAdvisory committeesExternal

Product reviews require expertisefrom different organizational unitsWithin the RA.  

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TFDA Review Process and Intra-agency Communications

Sponsor

Division of Medicinal Products

CDE

Recommendations 

Division of medicinal products

Final decision

Advisory Committee

As needed

External experts

Division of Risk Management

Investigation/evaluation

GMP certificate

Division of Research and Analysis

Quality reconfirmation

certificate

(for biologics)

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Communications

Other authority

The public The applicants

External experts

Regulatory authorityInter‐agency

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Inter-agency communication

• Can increase the efficiency and quality of medical product development and review process

• Usually needs an inter‐agency agreement in a form of MOU (Memorandum of Understanding), confidentiality arrangements, and consent from the applicants 

• Types of communications‐– Published guidelines, application decisions, available review reports to 

effectively facilitate the review and decision making– Actively pursuing reviews during review, e.g., non‐clinical, clinical and 

inspection findings– Joint nation review of applications if possible

• Establishing format and process of communications to comply with nation’s laws and inter‐agency agreement

Application decision is still up to the Nation

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Examples of Interagency Communication with TFDA

Sharing and awareness of information:Participation of international or regional harmonization initiatives, such as

membership in APEC, ICH, IPRP and PIC/SHosting APEC GRM CoE training events Information exchanges with other regulatory authorities

– Annual joint conference of Taiwan and Japan on Medical Products Regulations– Collaboration document over Pharmaceutical regulations with NPRA– Workshops featuring experts from other authorities

Posting regulatory actions– Assessment reports for approved NCE– Information of domestic and international manufacturers conferred with GMP

certificates by Taiwan regulatory authorities

Consideration of review findings:New drugs review scheme pilot with PMDA

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Communications

Other authority

The public The applicants

External experts

Regulatory authority

With the applicants

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Communication with applicants

Before and after submissions, and during regulatory review Published available guidelines provide insights into RA’s current thinking

and expectations for better quality submissions and compliance Important timelines

– Product development or pre-IND and IND stage (getting more important)– Pre-NDA – During NDA reviews– Postmarketing requirements

Establishing format and process of communications – Formal meetings, submissions, e.g., face-to-face meeting, teleconference, or

written response only (WRO)– Preliminary comments, final meeting minutes, and responses– Including feedback mechanisms

Nothing is final until all available information has been reviewed

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Consultation system in Taiwan

Consultation System 

Consultation by Request

Active Consultation

Industrial Communication 

Platform

Domestic Innovative Consultation 

(Early Harvest Lists)

National Research Program for Biopharmaceuticals

(NRPB)

Online Information

Transparency

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Expedited Programs for NDA

NDA review track 

Regular

Standard Review(360 days)

Abbreviated Review

(180 days)

Unmet medical needAA applicable

Priority Review(240 days)

Priority + Abbreviated

Abbreviated Review：NCE  + US FDA, EMA, MHLW approved (2 in 3) AA: Accelerated approval (AA): Surrogate endpoint CT accepted

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Review Timeline Management

Normal Review

Priority Review

(needs TFDA pre-approval)

Abbreviated Review

(needs TFDA pre-approval)

Non-NCE NDA

(w/ clinical data)

Non-NCE NDA

(w/o clinical data)

TFDA decision

(D360)(D60) (D120)

(D240)(D60) (D120)

(D60) (D90) (D180)

(D300)(D60) (D120)

(D60) (D200)(D90)

M1 M2 M3 M4 M5 M6 M7 M8 M9 M10 M11 M12

(D50)

(D50)

(D50)

(D50)

(D50)

(D100)

(D100)

(D100)

(D80)

(D80)

(D210)

(D170)

(D120)

(D180)

(D140)

Filing Meeting

Review Meeting

(D300)

(D200)

(D140)

(D240)

(D160)

Complete assessment reportInquiryRTF (Refuse 

to file)

Predictability

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Communication between reviewers and sponsors

Formal pre-submission consultation Consultation on development of new drugs (domestic companies only) Letters of inquiry Sponsor requested meeting Over-the-phone information (informal) Over-phone discussions (for applications of post-approval variation only) Appeals against final decision

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Types of Advice- Examples

• Critical advice  – trial design, dose selection, nonclinical study, manufacturing and facility issues 

• Regulatory plans for submission • Clinical/statistical outcomes and endpoints, trial size, enrichment 

designs, Pediatrics• Safety, the overall safety database, concerns related to particular 

populations, post‐approval pharmacovigilance plans, risk evaluation and mitigation strategies, plans for human factors studies, issues related to evaluation of abuse potential

• Clinical pharmacology and pharmacokinetics • Nonclinical pharmacology, pharmacokinetics, and toxicology • Product quality, e.g., proposed shelf life and stability studies, 

delivery systems, GMP

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Communications

Other authority

The public The applicants

External experts

Regulatory authorityWith externalexperts

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Communications with external experts

• Academics, patient and medical organizations• Enhancing the available information for better decision 

making process• Timely planning the pursuit of applicable experts• Establishing format‐

– Advisory panels for public opinions– Individual invitation for specific issues– Maintaining confidentiality and conflict of interest

Still, the Nation has the final decision based on all available information  

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Communications

Other authority

The public The applicants

External experts

Regulatory authority

With thepublic

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Communications with the public

• Policies and procedures for guidelines, decision‐makings, reviews, and accomplishments for public access

• Mechanisms for public input– Website postings requesting for input, surveys, public meetings, workshops, advisory boards, medical organizations, etc.

– For product development, regulatory review, and postmarketingrisk management strategies  

• Clear messages avoiding public panicking

Many factors affecting RA’s ability to develop, disseminate, and oversee effective product communications in an 

evidence‐based manner

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Information for the public in Taiwan

More information in Chinese website

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Publications for the public in Taiwan

Food & Drug Consumer Newsletter (weekly) Medication Safety Handbook for New Immigrants(with Thai, Cambodian, bahasa Indonesia, Vietnamese versions)

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Considerations In Issuing a Communication to the Public

• When and what to issue the communication, including if the issue has been communicated before

– Strength of the evidence• Issuing party• Target audience(s) • Key messages to communicate‐ quality, risk/potential risk, 

requesting input?• Is the communication related to a regulatory action?• Are there communications to HCPs and patients that is consistent 

with medical practice without unintended or unanticipated consequences?

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Dynamics of Communication

Regulatory Authority

Company

Patients

Public

Medical Community

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Challenges in Communications

The science and transparency of decision making process, especially when uncertainties of evidence occur

How to manage communication in media channels? Nation’s unique culture Moving forward- also need to seek ways to

– measure the effectiveness – understand the audiences, e.g., nations, partner organizations,

languages, and uncertainty in messages

More development on the best practice of communications may be needed

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Potential Topics for Discussions

What are the current communication practices in your institution?

Have you reached the goal of good communication in your institution? What are the gaps?

What is your planned solution to address the gaps in communication?

How do you assess the impact of improved communication?

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Thank you for your attention !