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China Expediting the Review and Approval of Drugs to Treat Life Threatening Diseases

Chinese health authority published a list with 48 orphan drugs that qualify for an expedite review process of their registration application. The 48 drugs are used for the treatment or prevention of rare and life-threatening diseases, and have alread…

FDA Waiving the Informed Consent for Minimal Risk Clinical Studies

To date, FDA requires all subjects to provide their informed consent before participating in any clinical trial, except when there are life-threatening situations or emergency research conditions.

On November 2018, FDA proposed a new rule that wil…

FDA New Pilot Program for Medical Device Conformity Assessment Accreditation

By September 20120, the US Food and Drug Administration (FDA) is planning to lanch its pilot program for medical device conformity assessment accreditation, known as the Accreditation Scheme for Conformity Assessment (ASCA).

ASCA Pilot Program goa…

How FDA Defines Substantial Equivalence to Predicate Devices

The concept of substantial equivalence of medical devices was introduced by the US Food and Drug Administration

Overview of Pre-Sub (Sub-Q) Meeting with FDA

A Pre-sub, called also Q-Submissions” or “Q-Subs” is a formal written request to FDA made by an applicant

New FDA Pilot Program for 510(k) "Quik" Review

FDA has launched a new pilot program for a “Quick Review“ of 510(k) of certain medical devices, by using the eSubmitter software to format the submission. The devices that qualify for this quick review, as shown on list below, are moderate risk devic…

CFDA Announced Major Changes to Chinese Medical Device Regulations in favor of Foreign Manufacturers

Japan PMDA Raising Medical Device Registration Fees

[vc_row][vc_column][vc_column_text]On April 1st, 2018, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has raised the registration fees for most medical devices . PMDA fee increase is ranging from 8% to 15% across nine device categories as …

Sponsor Responsibilities for IND

Means an individual who actually conducts a clinical investigation….

Sakigake Designation for Drugs in Japan

PMDA created a new regulatory pathway known as “SAKIGAKE” that allows the accelerated approval of drugs designated as breakthrough therapies and addressing unmet medical needs in Japan….

FDA is aligning its QSR (21 CFR 820) with ISO 13485:2016

Unique Device Identification (UDI) Systems Expansion in Europe

[vc_row][vc_column][vc_column_text css=".vc_custom_1520225945879"]The implementation of Unique Device Identification (UDI) systems in markets beyond the US is increasing, as the European Commission is planning to publish a guidance document on UDI un…

FDA New Pilot Program for Orphan Designation Requests

[vc_row][vc_column][vc_column_text css=".vc_custom_1520175523966"]For Rare Disease Day, the FDA lunched a new pilot program to streamline orphan designation requests to make it easier for applicants and reviewers. The program also includes a tutorial…

Formal Meetings with FDA

FDA encourages sponsors to consult the agency during their products’ development program through one of its 3 types of formal meeting (Type A, Type-B and Type-C). Each meeting has its own purpose and process….

Japan cutting prices of new drugs and off-patent drugs

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The Ministry of Health, Labor and Welfare is proposing a considerable cut down in the pricing of both off-patent drugs and expensive innovative treatments, and also set up an annual…

CFDA New Clinical Data Requirements for Foreign medical devices

[vc_row][vc_column][vc_column_text]CFDA has proposed changes to Order 650 that would exempt additional types of Class II and III medical devices and IVDs from clinical trial requirements, and a…

FDA New Guidance on De Novo Classification Process

[vc_row][vc_column][vc_column_text]On October 30, 2017 FDA published a new guidance that describes the process for the submission and review of a De Novo classification request for novel devices, that are automatically classified as Class III devices…

Overview of FDA 505(b)(2) Regulatory Pathway

Many 505(b)(2) applications do not require the sponsor to conduct nonclinical
studies. In these cases, the successful application will contain adequate
evidence of safety for the proposed product….

510(k) Pre-Market Notification

Establishment Registration and Device listing

US Representative

510k Premarket Notification

FDA New Premarket Approval (PMA) Pilot Program for High Risk Medical Devices

2018 FDA Small-Business Medical Device User Fees

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The US FDA has published new guidance explaining how companies should apply to qualify for small-business medical device user fees instead of much higher standard fees.

Generally, companies m…

FDA NEWS: Priority Review for Generic on the Way

Nanomaterial Submissions on the Rise

CFDA Proposes Draft Lowering Barriers for Foreign Drug Manufacturers

Do We Really Need Regulatory Intelligence?

QMS for Virtual Companies

Reality check on 505(b)(2) NDA Approval Pathway

China to offer Priority Review for Medical Devices from January 2017

Special Approval Procedures for Innovative Medical Devices in China

Unique Device Identification: A Global Perspective

CFDA Publishes New List of Medical Devices Exempt from Clinical Trial Requirements

Medical Device Single Audit Program (MDSAP) in Japan

A review of the changes in ISO 13485

‘’Overview of Authorization Procedures for Medicinal Products in Europe’’

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