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Set Alert for Manufacturing

Europe’s Proposed Chemical Ban Could Hit Many Thousands Of Global Marketing Authorizations

Drug manufacturing in the EU would grind to a halt in under three years if a proposal to restrict per- and polyfluoroalkyl substances in the European Economic Area is implemented in its current form, says industry group EFPIA.

Europe Drug Safety

WHO Seeks Feedback On Gaps In Current QA & GMP Guidelines

The World Health Organization has shortlisted over 30 quality assurance and good manufacturing practice guidelines that are over seven years old or need a major review.

International Guidance Documents

New Swiss Database To Cut Costs Of GMP/GDP Certification

A new database being set up in Switzerland is expected to improve the exchange of GMP and GDP information between the regulatory authorities and pharmaceutical companies and offer free access to electronic certificates.

Europe Switzerland

Lantidra’s First-Cycle Complete Response Letter Centered On Inspection And Product Quality Issues

Although the CRL delayed the cell therapy’s approval by almost two years, additional CMC-related testing requested by the FDA ultimately came to be seen as a good thing by sponsor CellTrans because it provided assurance of product consistency.

Drug Review Profile Complete Response Letters

Companies Need EU Funding To Cover ‘Enormous Expenditure’ Of Complying With Revised GMP Rules

Important updates to good manufacturing practice guidelines are likely to mean medicine shortages, warns a German pharmaceutical industry group.

Europe Manufacturing

Drug Shortage Legislation: House GOP Finds Support For Bill While Dems Offer Concerns, Alternatives During Hearing

A proposed 340B rebate exemption for generic sterile injectables appears headed for the final drug shortage bill House Republicans are preparing, despite Democrats’ worries the idea could increase shortages.

Legislation Manufacturing

US FDA: Pharmaceutical Distribution Entering DSCSA Compliance ‘Stabilization Period’

Agency officials advise drug supply chain partners what stabilization activities they expect to see during one-year “enforcement discretion” period; industry lawyers advise that anyone found coasting could face discretionary enforcement. More discretion, more guidance in the works, including a final ruling on state preemption.

Distribution Quality

Generic Drug Facility Post-Warning Letter Meetings Likely Will Hinge On ‘Reasonable Progress’

Facility owners should ensure they are ready when asking for the meeting on deficiency remediation because only two requests are allowed per warning letter.

Generic Drugs Manufacturing

The Quality Lowdown: Problems At Iso-Tex, Centaur, Biocon, Lupin And US Specialty

Hot, humid clean rooms, drug-caked equipment, stuck syringes, iffy contraceptives and iffy GMPs were among the pharmaceutical quality shortcomings that surfaced recently.

Manufacturing Quality

Firms Look To Upgrade Aseptic Processing Lines As EU GMP Annex 1 Revision Takes Effect Globally

Sterile drug manufacturers get one year to comply with most revisions in updated EU, PIC/S and WHO GMP Annex 1 guideline. PDA survey hints at scale of challenge facing firms that still use traditional open filling lines, a practice expected to end under the Annex 1 revisions.

Manufacturing Drug Approval Standards

South African Agency To Help National Regulators Build Up Their Capacities

RCORE designation means SAHPRA can support training and exchange programs as part of pan-African regulatory strengthening moves.

Middle East and Africa South Africa

Medicare Floats Essential Medicine ‘Buffer Stock’ Incentive For Hospitals

The US is proposing to pay hospitals extra to maintain reserve supplies of ‘essential medicines’ to help mitigate shortages. But would the plan only make the problem worse?

Manufacturing Medicare

As Supply Chain Partners Ramp Up For November DSCSA Deadline, US FDA Gives Them Another Year

Potential distribution hitches could spark shortages of legitimate drugs if the system is not fully ready for package-level tracing requirements, US FDA says in delaying enforcement of the program a decade in the making. Poll shows supply chain partners were making significant progress in preparing for the 27 November deadline.

Distribution Legislation

India’s Generics-Only Rx Rule: Not What The Doctor Ordered Or What Pharma Wants?

New norms call for generics-only prescriptions and prohibits doctors from engaging in third-party educational activity backed by pharma in India. Will pharma need to rethink its branded generics strategy in India or will questions about quality assurance sink the rules?

Regulation India

Philippines Strengthens Drug Surveillance With Mandatory Import/Export Notification Rule

The Philippines FDA explains how it intends to implement new requirements under which the import/export of each drug shipment will have to be notified by companies a month in advance.

Philippines Guidance Documents

Many Drug Manufacturing Sites Pay A Stiff Price For Ignoring US FDA Remote Records Requests

The FDA has been import-alerting more and more facilities for failing to respond to its remote records requests, FDA compliance official says. Meanwhile, it appears the agency’s generous exercise of regulatory discretion during the pandemic in cases of serious noncompliance is coming to an end.

Manufacturing Quality
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