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Mexico Launches ‘Regulatory Certainty Strategy’ For Biosimilars

Mexico is to establish a new regulatory framework that is in line with international standards to encourage domestic production of biosimilar medicines. 

North America Mexico

Global Pharma Guidance Tracker – January 2024

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Guidance Documents Regulation

Canada Attacks Florida’s ‘Bad’ Bulk Importation Plan

Regulatory tools designed to prevent medicines intended for Canada being diverted elsewhere will be “crucial” for preventing shortages in the country, say Canadian authorities and industry representatives.

North America Canada

EMA Steps Up Support For Creation Of African Medicines Agency

The EU drugs regulator plans to provide the expertise needed to make the African Medicines Agency operational and to help develop the capabilities of the African drug regulatory network.

Europe Middle East and Africa

Regulatory Reliance Pathways: Challenges And Opportunities Ahead

International interest in fast-track regulatory reliance and collaboration pathways such as Project Orbis and the ACCESS Consortium has grown in recent years, a trend that looks set to continue in 2024. But some policy experts have warned that faster approvals are not always better, with one academic claiming the bar for marketing authorizations has dropped “far too low.”

BioPharmaceutical Drug Review

Brazil Updates GMP Rules For Advanced Therapies

Brazil brings advanced therapy GMP regulations into line with international standards.

South America Brazil

Drug Importation And Medicaid: Trump Era Guidance Likely Disincentivizes Use

CMS guidance on the Medicaid Drug Rebate Program, best price and drug importation from 2020 should make it less attractive for states to implement importation programs and help pharma.

Canada United States

South Africa & Zimbabwe Sign Deal On Joint Drug Reviews, Inspections

SAHPRA and MCAZ have signed an MoU to cooperate with each other on medicines regulation, quality control and pharmacovigilance. 

South Africa Zimbabwe

Global Pharma Guidance Tracker – December 2023

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Guidance Documents Regulation

FDA Authorizes Florida Importation Plan, But No Drugs Cleared For Landing

The US FDA's authorization of the first ever Section 804 importation program is a notable political move, but hurdles remain before the state can import drugs and savings are expected to be minimal.

Pricing Debate Supply Chain

Brazilian Regulator OKs ‘Skinny Labeling’ But Legal Situation Remains Unclear

Anvisa believes there are no legal obstacles to its rule allowing generic products to have different indications from the reference drug, but some say the move could lead to challenges unless it is backed by legislative change.

Brazil Intellectual Property

New Canadian Drug Agency To Focus On Drug Access & Affordability

The newly created agency will build on the mandate and functions of the health technology assessment body, CADTH.

Canada Market Access

Brazil Aims For Top 10 Spot In Clinical Research

A new bill has been hailed as a “significant step” towards harmonizing rules in clinical research and promoting safe and ethical scientific advances.

South America Brazil

How The ACCESS Consortium’s New ‘Promise Pathway’ Can Benefit Drugmakers

Pharmaceutical companies that develop new medicines for life-threatening or severely debilitating conditions could be eligible to file for a priority review in the five ACCESS Consortium member countries under a new pilot scheme.

International Europe

Global Pharma Guidance Tracker – November 2023

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Guidance Documents Regulation

‘Historic’ New Funding Mechanism To Boost African Vaccine Production

Up to $1bn in incentive and milestone payments is to be offered to manufacturers over a 10-year period, focusing on priority antigens and diseases.

Middle East and Africa Manufacturing
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