2025, Packaging and Pharmaceuticals - Drug Discovery Digest

Get Prepared for New Plastic Packaging and Manufacturing Materials Requirements

PPD

JULY 20, 2023

In clinical research, the role of drug packaging systems cannot be overlooked. Industry guidelines require biopharmaceutical and biotechnology companies to test their pharmaceutical packaging systems, as the systems often experience prolonged and intimate contact with drug products, drug substances and intermediates.

Packaging

Packaging Laboratories Pharmaceutical Companies Compliance

Article EMA Thank You What we expect European regulators to do in August and September 2024

Agency IQ

AUGUST 2, 2024

Another legislative area that will also likely receive more attention will be the pharma reform package , since the two Parliament rapporteurs to lead the package negotiations were recently appointed. All clinical trials still ongoing must transition to the Clinical Trials Regulation by January 31, 2025 to ensure continuity.

Regulations

Regulations Clinical Trials Production International

Article EMA Thank You EMA publishes first electronic Product Information as pilot progresses

Agency IQ

NOVEMBER 20, 2023

readability of package leaflet, patient engagement). Summary of Product Characteristics and Package Leaflet), recommending that sponsors and regulators “explore the use of electronic media” to provide product information “in the future”. The report recognized the potential for an electronic format for Product Information (i.e.,

Production

Production Packaging Hospitals Regulations

Sanofi expands its social commitments, creates nonprofit unit to provide poorest countries with access to essential medicines

The Pharma Data

APRIL 7, 2021

Yet as challenging as 2020 was, it also brought us –Sanofi and the pharmaceutical industry– closer to our purpose than at any other time in living memory ,” said Hudson. Zero plastic packaging for vaccines and ecodesign of products. The company is also committed to ecodesigning all its new products by 2025.

Packaging

Packaging Vaccine Disease Treatment

Article EMA Thank You What we expect European regulators to do in June 2024

Agency IQ

MAY 31, 2024

Even small changes in the Parliament’s composition could have an impact on ongoing legislative discussions, such as the revisions to the pharma reform package. The current European Parliament and Commission have confirmed their position on the pharma package, but the European Council is still working on its negotiation position.

Regulations

Regulations Production Compliance Pharmaceuticals

Article EMA Thank You What we expect European regulators to do in November 2023

Agency IQ

OCTOBER 27, 2023

Comment periods for EMA documents (such as concept, reflection, and guidance papers) generally stay open for at least six months, though these timelines can vary drastically. policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected through Q1 2024.

Regulations

Regulations Pharmaceuticals Production Packaging

Transcending expectations for cell & gene therapy development

Drug Discovery World

JULY 11, 2022

It has been estimated that by 2025 the FDA will be approving 10 to 20 cell and gene therapy products per year 2. For regulatory purposes, they may be treated more like a pharmaceutical or a blood product. " Critical Considerations For Packaging And Delivery Of Gene Therapy Products." Molecular therapy.

Therapies

Therapies Clinical Trials Production Trials

Article EMA Thank You European Commission reveals action plan to address medicines shortages

Agency IQ

NOVEMBER 3, 2023

The Pharmaceutical Group of the European Union (PGEU) conducted a survey finding shortages worsened in 2022 compared to 2021, with most European countries reporting worsening. The Pharmaceutical Strategy document notes that Covid-19 just compounded medicines shortages that had already impacted patient health and the E.U. wide level.

Regulations

Regulations International Pharmaceuticals Production

Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

Agency IQ

JANUARY 19, 2024

Commission unveils “one substance, one assessment” reform package The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. Data from pharmaceutical legislation is not included by default, though some specifically named pharma data relating to chemicals will be encompassed.

Packaging

Packaging Regulations Laboratories Animal Testing

Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Agency IQ

JULY 8, 2024

Letter Program Tag Commitment Due Date PDUFA Advancing RWE Program Report containing aggregated and anonymized information describing RWE submissions to CDER and CBER. and the E.C.

FDA

FDA Science Regulations Production

Article EMA Thank You New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., Great Britain, and the E.U.

Agency IQ

AUGUST 4, 2023

pharmaceutical law ceased to apply to the U.K. s Medicines and Healthcare products Regulatory Agency (MHRA) has been releasing guidance for the pharmaceutical and medical device industry to aid product development and approval after the separation. on June 20, 2023 and will apply starting January 1, 2025. as of January 1, 2021.

Packaging

Packaging Licensing Licensing Regulations

Fujifilm to Invest Over 200 Billion yen (2 Billion USD) to Establish New Large-Scale Cell Culture Manufacturing Site for Biopharmaceuticals in the U.S.A.

The Pharma Data

JANUARY 6, 2021

End-to-End Single-Site Solution from Drug Substances to Fill-Finish & Packaging. In addition to drug substance manufacture, the facility will also provide commercial scale, automated fill-finish and assembly, packaging and labeling services. Packaging line?. Spring 2025. TOKYO , Jan.

Packaging

Packaging Small Molecule Production FDA Approval

Transitioning to eCTD v4.0

The Premier Consulting Blog

APRIL 27, 2023

Then, in 1997, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) formed the ICH M8 Expert Working Group/Implementation Working Group (EWG/IWG). Sponsors should prepare by reviewing implementation packages from the ICH and applicable regions. Implementation Package v1.5

Packaging

Packaging FDA International Pharmaceuticals

Article EMA Thank You What we expect European regulators to do in May 2024

Agency IQ

MAY 3, 2024

The pharma reform package remains in E.U. voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. leaders’ eyesight as the Parliament winds down ahead of its June elections. On April 10, the E.U. On April 10, the E.U.

Regulations

Regulations Clinical Trials Production Biosimilars

Analysis Life Sciences Thank You FDA lays out new assessment framework for certain nitrosamines

Agency IQ

AUGUST 11, 2023

BY KARI OAKES AUG 7, 2023 10:20 PM CDT Quick background on nitrosamines in pharmaceutical products Nitrosamines are a large and diverse class of chemicals, with more than 300 different structurally distinct species known today. In 2018, NDMA was first detected in the active pharmaceutical ingredient (API) for valsartan, a blood pressure drug.

FDA

FDA Science Production Regulations

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

JUNE 16, 2023

The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda. The anticipated date of publication is June 2023, meaning we should see this regulation imminently. Read our analysis of that rule here and here. ]

Regulations

Regulations FDA Science Production

Analysis Life Sciences Thank You Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024

Agency IQ

JULY 22, 2024

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). Data on these novel approvals is published throughout the year by both CDER and CBER.

Clinical Trials

Clinical Trials Trials Science FDA

Article EMA Thank You Commission proposes guidelines to flesh out the newly finalized Variations Regulation

Agency IQ

JUNE 21, 2024

That same year, the Pharmaceutical Strategy for Europe called for a revision of the Variations Regulation and an evaluation of the existing legislation. In April 2023, the Commission issued proposals to revise the current pharmaceutical Directive and Regulation. The delegated regulation will apply beginning January 1, 2025.

Regulations

Regulations Marketing Production Vaccine

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Agency IQ

JULY 12, 2024

A closer look at the seven new proposed regulations Stage of Rulemaking Title Estimated Publication Synopsis Proposed Rule Amendments to the Current Good Manufacturing Practice Regulations for Drug Products February 2025 FDA is proposing to amend the Current Good Manufacturing Practice Regulations for Drug Products. and the E.C.

Regulations

Regulations FDA Science Production

Analysis Chemical Thank You The 174 regulations the EPA is currently working on

Agency IQ

DECEMBER 15, 2023

Meanwhile, EPA has extended the release of the final rule for Updates to New Chemicals Regulations under TSCA from April 2024 to February 2025. For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022.

Regulations

Regulations Compliance Production Government

Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

Agency IQ

JUNE 16, 2023

This action proposed the applicable volumes and percentage standards for 2023 through 2025 for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel. This package would propose updates to the alternative work practice as appropriate based on the review and address the issues raised for reconsideration.

Regulations

Regulations Compliance Production Science

Drug Discovery Digest

Get Prepared for New Plastic Packaging and Manufacturing Materials Requirements

Article EMA Thank You What we expect European regulators to do in August and September 2024

Trending Sources

Article EMA Thank You EMA publishes first electronic Product Information as pilot progresses

Sanofi expands its social commitments, creates nonprofit unit to provide poorest countries with access to essential medicines

Article EMA Thank You What we expect European regulators to do in June 2024

Article EMA Thank You What we expect European regulators to do in November 2023

Transcending expectations for cell & gene therapy development

Article EMA Thank You European Commission reveals action plan to address medicines shortages

Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Article EMA Thank You New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., Great Britain, and the E.U.

Fujifilm to Invest Over 200 Billion yen (2 Billion USD) to Establish New Large-Scale Cell Culture Manufacturing Site for Biopharmaceuticals in the U.S.A.

Transitioning to eCTD v4.0

Article EMA Thank You What we expect European regulators to do in May 2024

Analysis Life Sciences Thank You FDA lays out new assessment framework for certain nitrosamines

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Analysis Life Sciences Thank You Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024

Article EMA Thank You Commission proposes guidelines to flesh out the newly finalized Variations Regulation

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Analysis Chemical Thank You The 174 regulations the EPA is currently working on

Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

Stay Connected