Last week’s round -up;
25-29 October 2021

Antimicrobial Resistance – expected regulatory implications

Activities of the Transatlantic Taskforce on Antimicrobial Resistance (TATFAR) are expected to have regulatory implications. Mentioned within their current progress report are agreements on clinical trial recommendations that will be reflected in updated guidance documents for several different types of bacterial diseases. Also identified for continued collaboration up till 2026 are strategies to improve financial incentives, access, research, and development of antimicrobial drugs, diagnostics, and alternatives. Furthermore, the definitions for multidrug-resistant (MDR), extensively drug-resistant (XDR) and pan-drug-resistant (PDR) bacteria for human infections will be revised.

https://lnkd.in/euK-FM_f

Japan’s PMDA posts English translation of guidelines for bioequivalence studies

Japan’s PMDA has released an English translation of guidelines and questions and answers on bioequivalence studies of generic products.The guidelines cover bioequivalence studies, dissolution tests and other assessments for various dosage forms, including oral immediate release and oral extended-release products. The guideline also features a shorter section on non-oral dosage forms and dosage forms for which bioequivalence studies are waived.

https://bit.ly/RealCMC-3EsokCu

Guidance on good lay summary practice

Guidance on good lay summary practice (GLSP) has recently been published by the European Commission. The guidance provides recommendations on how to prepare, write, translate, and disseminate summaries of clinical trial results in lay language, and was adopted by the expert group on clinical trials in July 2021. Sponsors should note that lay summaries on each clinical trial are a mandatory requirement of the upcoming Clinical Trial Regulation. Relatedly, the guidance highlights mandatory requirements under the regulation, and those which are optional recommendations based on ethical obligations and related best practices.

https://lnkd.in/dzJMMANW

Updates from the EDQM

The EDQM has released the following updates:

• A revised osmolality chapter for public comment in Pharmeuropa. The revised chapter focuses on osmolality reference solutions using sodium chloride that are required for instrument verification. The deadline for comments is the 31st December 2021.

• The Pharmacopoeial Discussion Group is preparing a pilot for global expansion of membership to integrate additional world pharmacopoeias.

• CEP holders are invited to comment on draft monographs published in Pharmeuropa 33.4. The deadline for comments is 31st December 2021.

• CEP holders are invited to update their applications according to the revised monographs published in Ph. Eur. Supplement 10.7 that will be implemented on the 1st April 2022.

https://bit.ly/RealCMC-3nTq1lN

Public consultation on EU pharmaceutical legislation

The European Commission has launched a public consultation on the revision of the EU’s pharmaceutical legislation. The consultation will last until 21st December 2021 and will gather views from stakeholders and the general public. The last review of the EU’s pharmaceutical legislation took place almost 20 years ago and the overarching aims of this revision are: to ensure access to affordable medicines, foster innovation, improve security of supply, adapt to new scientific and technological developments, and reduce red tape. In the consultation, the EC also asks if there are other problems it needs to address.

https://lnkd.in/d6snDbtU

The EMA’s tailored scientific advice offering for biosimilar development will be continued

In its report on the initial pilot offering of tailored scientific advice for new biosimilar development, the EMA has announced that this will be continued as part of regular scientific advice operations. When using the procedure, developers are advised on the studies they should conduct, based on a review of the quality, analytical and functional data they already have available. The service will be capped at a maximum of 2 procedures per month, and the duration is set to 70 days if managed without a discussion meeting or 100 days if such a meeting is needed.

https://lnkd.in/eW6FtBem

Updated Q&A on GMP compliance for IMPs

The European Commission has released an updated Q&A no. 8.4 on the Clinical Trials Regulation 536/2014. The updated Q&A covers the documentation that is required to show compliance of an IMP and AxMP with GMP, which is also outlined in Chapter IX and Annex 1 section F of the CTR:

• No documentation is required for IMPs authorised in the EU (even if not manufactured in the EU).

• For IMPs that are not authorised in the EU and do not have an MA from a third country that is party to ICH, and are not manufactured in the EU, an authorisation referred to in article 61(1) and a QP declaration of GMP equivalence is required. In the latter case, if a Mutual Recognition Agreement (MRA) covering clinical trials is in place with the particular country, the latter declaration is not required if the MRA provides for GMP equivalence already.

• An authorisation according to article 61 of the Clinical trial Regulation is required for all other cases.

• Information regarding the GMP compliance of APIs is not required by the CTR (and can therefore not be required by the Member States concerned).

 https://bit.ly/RealCMC-3GpA3n5

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Last week’s round -up;
18-22 October 2021

Final EMA feedback on Titanium Dioxide

The EMA has issued its final feedback to the EU Commission request to evaluate the impact on medicinal products of the removal of titanium dioxide from the list of authorised food additives. The request from the Commission was triggered by the opinion of the European Food Safety Authority (EFSA), published in May 2021: “that on the basis of all currently available evidence along with all uncertainties, in particular the fact that genotoxicity could not be ruled out, titanium dioxide can no longer be considered as safe when used as a food additive”. The Commission requested the EMA’s analysis in order to define the technical purpose of titanium dioxide in medicinal products, the feasibility of alternatives to replace it without negatively impacting the quality, safety and efficacy of medicines, and if confirmed, considerations to be taken into account to define a transition period for phasing out this excipient. The EMA concluded that the feasibility of replacing titanium dioxide cannot be confirmed at this stage, and an acceptable transition period is currently difficult to envisage or estimate.

https://bit.ly/RealCMC-3aXr7H3

ICH guideline proposes daily limits for seven mutagenic impurities

The International Council for Harmonization (ICH) issued its M7(R2) guideline for public consultation. The guideline sets new permitted daily exposure (PDE) limits for seven DNA-reactive substances to limit their carcinogenic risk. The guideline contains 21 mutagenic impurities including the following 7 newly added impurities with their PDE levels: · Acetaldehyde: (oral) 2 mcg/day – 185 mcg/day for all other routes · 1,2 Dibromoethane: 2 mcg/day · Epichlorohydrin: 3 mcg/day · Ethyl bromide: 32 mcg/day · Formaldehyde: (inhalation) 8 mcg or 215 parts per billion/day; all other routes 10 mg/day · Styrene: 154 mcg/day · Vinyl acetate PDE: (oral) 2 mcg/day – 758 mcg/day for all other routes The guideline has now been split up into one main guideline and an addendum containing PDEs or acceptable intake (AI) levels for each impurity, along with their monographs. It provides rationales for including the new mutagenic impurities.

https://bit.ly/RealCMC-3C2AXTQ

New partnership between HRA and ISRCTN for public registration of UK clinical trials

The UK Health Research Authority (HRA) has announced a partnership with the ISRCTN primary clinical trial registry for the automatic public registration of clinical trials. From 2022, the HRA will register clinical trials in the UK which receive a favourable ethics opinion with ISRCTN directly, using data from the HRA’s systems, so research sponsors and researchers will no longer need to apply for public registration separately. Further details are available on the HRA and ISRCTN registry websites.

Guidance links:

https://bit.ly/RRL-3vGXYJC

https://bit.ly/RRL-2ZjncBw

Dasatinib product-specific bioequivalence guidance

The EMA has issued a revised product-specific bioequivalence guidance for Dasatinib film-coated tablets 20, 50, 70, 80, 100 & 140 mg and suspension 10 mg/ml. This revised product-specific guidance for dasatinib includes the additional requirement for a fed study and the requirements for a suspension.

https://bit.ly/3cLNY7P

New Oxygen (98%) Ph. Eur. monograph

A new draft Ph. Eur. monograph for Oxygen (98%) has been published for comment in Pharmeuropa 33.4. The draft monograph is the outcome of a thorough examination of feedback from regulators, hospital pharmacists, industry representatives (gas producers and producers of oxygen generating equipment) and academics. The draft monograph is available for comment until 31st December 2021.

https://bit.ly/RealCMC-3n2F2RC

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Last week’s round -up;
13 -17 September 2021

New EMA Product-Specific Bioequivalence Guidance

The EMA has adopted the following new product-specific bioequivalence guidance, which come into effect on the 1st November 2021:

· Acenocoumarol, tablet, 1 mg and 4 mg

· Lapatinib film-coated tablet 250 mg

· Palbociclib hard capsule 75 mg, 100 mg and 125 mg and film-coated tablet 75 mg, 100 mg and 125 mg

https://bit.ly/2UVpfae

FDA’s novel excipient pilot program opens for candidates

The FDA has launched a new pilot program to review novel excipients for use in meeting unmet needs in formulating new drug products. The Authority will accept four initial proposals in the pilot “but will consider accepting more proposals as resources allow.” The following criteria will be used to select candidates:

· The potential public health benefit of the novel excipients; for example, such applications as use in opioid abuse-deterrent formulations or to promote new therapies for serious and life-threatening disease.

· The likelihood of the novel excipient manufacturer’s ability to submit a complete package within the established timeframe.

· The potential of the novel excipient to “meaningfully improve pharmacokinetic characteristics” and lead to the development of novel drugs. Following acceptance of the initial proposals, the excipient manufacturers concerned will then be requested to submit a full toxicology package as well as chemistry, manufacturing, and controls data in a process parallel to that for an investigational new drug application. Proposals for novel excipients are being accepted until the 7th December 2021.

https://bit.ly/RealCMC-3zkrUeZ

New Ph. Eur. general chapter on balances

The Ph. Eur. Commission has adopted a new general chapter Balances for analytical purposes (2.1.7), which has been published in Supplement 10.6 in July 2021. This new chapter fills a gap in section 2.1 Apparatus by setting out clear requirements for the use of analytical balances, as weighing is one of the most critical tasks carried out in the laboratory since even the smallest error will affect the accuracy of results. The chapter covers installation and use of analytical balances, including good practices for weighing vessels and provides detailed information on calibration and performance checks. These checks focus on two weighing parameters that most significantly affect balance performance, repeatability and sensitivity. The result of the repeatability test described in the text can also be used to calculate the minimum weight of the balance. The new chapter complements existing guidelines for the use and qualification of balances. It is supplemented by the instructions related to “Quantities” given in the recently revised General Notices chapter, which is due to be published in Supplement 10.7.

https://bit.ly/RealCMC-3hrUFQD

 

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Last week’s round -up;
30 August – 03 September 2021

New and Revised FDA Product-Specific Guidance

The US FDA has issued 23 new and 16 revised draft product-specific guidances which are intended to facilitate generic drug development, especially for medicinal products for which there are no approved generics. The newly issued guidance documents involve some products used to treat HIV, chronic obstructive pulmonary disease (COPD) and Cushing’s disease. Some of the new guidances for complex products cover ipratropium bromide nasal spray, ipratropium bromide inhalation spray and olodaterol hydrochloride inhalation spray. The FDA has also issued product-specific guidance for Type 2 diabetes drug semaglutide, which offers two paths to establishing bioequivalence.

https://lnkd.in/dU7Q26pn

Herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids

The EMA has released a revised public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs). The document also includes recommendations regarding contamination of herbal medicinal products with PAs. Several PAs are regarded as both hepatotoxic and carcinogenic and are natural constituents of a number of plants used for medicinal purposes. This guidance describes chemical, toxicological, pharmacological and pharmacokinetic properties of PAs and sets out recommendations for the oral and cutaneous use of herbal medicinal products and traditional herbal medicinal products containing PAs. The revised public statement is a result of a review of newly available data and improved evaluation methods.

https://lnkd.in/egibCu6g

MHRA Guidance on Transfer of Analytical Methods

The MHRA Inspectorate has released new guidance for manufacturers and contract testing laboratories related to the process of transferring a method for outsourcing of testing. The Inspectorate has highlighted that the new guidance complements the requirements of EU GMP Chapter 7. The new guidance covers the formal process for the introduction of new methods which allows the receiving laboratory to demonstrate that they can perform the analytical method effectively and reproducibly. It also highlights that regulatory compliance is a shared responsibility between the transferring and receiving laboratories and a collaborative approach is encouraged. The MHRA has also recommended the use of risk management principles for analytical method transfer and the generation of a transfer report following a successful or even unsuccessful method transfer. A list of common shortcomings related to analytical method transfer is also included in the guidance.

https://lnkd.in/eQM2tWqp

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Last week’s round -up;
09-13 August 2021

Revised WHO guidance on GMP for investigational products and R&D facilities

The WHO released a revised draft guidance to industry addressing GMP for investigational drug products and new draft guidance on GMP principles for research and development (R&D) facilities in the context of the COVID-19 pandemic. The guidance on GMP for investigational drug products contains news recommendations on GMP issues related to quality management, quality risk management, personnel and documentation considerations. Issues related to manufacturing premises, equipment and utilities, materials and production are also addressed. Sections on the quality unit, qualifications and validation, complaints, recalls, returns, shipping and destruction are also covered. Some of the new recommendations include the requirement for a responsible person to be designated for the release of batches. The GMP guidance related to R&D facilities covers quality management and quality risk management in product research and development. It includes recommendations on sanitation and hygiene, qualification and validation, outsourced activities, self-inspection and quality audits, personnel training, premises, equipment and instruments and materials, documentation, processing and process design, quality control, stability and technology transfer.

Both draft guidelines are available for comment until 31st August 2021:  https://bit.ly/RealCMC-2VU4jUD

New EMA Q&A on Clinical pharmacology and pharmacokinetics

The EMA has released a new Q&A 6.5 on Clinical pharmacology and pharmacokinetics. The new Q&A gives recommendations on how large the deviations from proportionality in composition can be in the case of fixed combinations with highly soluble active substances in an application with multiple strengths. For fixed combinations (FCs) consisting of multiple strengths, small differences in proportionality of compositions may preclude the waiver of the additional strength and result in the request of an additional in vivo bioequivalence study. However, in the case that all the active substances in the FC belong to BCS Class I or III drugs (highly soluble active substances), the risk of non-bioequivalent additional strength formulations is negligible, if the conditions specified in the Q&A are fulfilled. Therefore, a waiver for additional strengths is acceptable even though the additional strengths deviate from proportionality in composition, provided the conditions are met.

https://bit.ly/30oSmGp

UK MHRA publishes the new Access Consortium Strategic Plan for 2021-2024

The Access Consortium is committed to maximizing collaboration by aligning regulatory and policy approaches, reducing duplication, and facilitating the member country populations’ access to high quality, safe and effective health products. This group originally consisted of the regulatory authorities in Australia, Canada, Singapore and Switzerland (previously referred to as ACSS). With the addition of the UK MHRA in October 2020, ACSS changed its name to Access Consortium, and now represents a collective population base of 150 million people across the 5 member countries. The Access Consortium has now published a three-year strategy covering 2021-2024, and further information and the document itself can be found through the following link: https://bit.ly/RRL-3g88UJV

Reflection paper on GMP and Marketing Authorisation Holders

The EMA has adopted the Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders. Although many MAH companies are not directly involved in the manufacture of medicinal products themselves, the current European Commission Guide to GMP refers, in several places, to MAHs and their responsibilities in relation to GMP. The new Reflection Paper provides clarity as to what the various responsibilities are and what they mean for MAHs at a practical level. This reflection paper also addresses the various legislative provisions (i.e. in European Directives, Regulations and in other guidelines) which relate to GMP and which concern MAHs.

https://bit.ly/RealCMC-3xypFn5

UK MHRA issues updated guide to “defective medicinal products”

The MHRA Guide to Defective Medicinal Products regarding reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC) has been updated, and can be found at the following link: https://bit.ly/RRL-2VHcTFT

CMDh Meeting Report – July 2021

The CMDh has released a report on the meeting that was held on 20th-21st July 2021. Various topics were tackled during the meeting including the following:

· An update to the CMDh Questions & Answers on implementation of outcome of Art. 31 referral on angiotensin-II-receptor antagonists (sartans) containing a tetrazole group – As outlined in Q7, under Condition B a response to the Article 5(3) referral is always needed for sartans containing a tetrazole group. Therefore, since it is considered that a risk of nitrosamines is always present for tetrazole sartans, due to their chemical structure, a Step 2 response is always expected and MAHs who previously submitted a Step 1 ‘no risk’ response, are expected to reconsider and submit a Step 2 response.

· Active Substance Master File (ASMF) worksharing – The CMDh strongly recommends the use of ASMF worksharing to save resources and promote a harmonised assessment when submitting an application for a medicinal product containing an ASMF.

https://bit.ly/RealCMC-3Ass5p8

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Last week’s round -up;
14-18 June 2021

Draft PIC/S EU Annex 16 on batch release by QPs

The Pharmaceutical Inspection Cooperation Scheme (PIC/S) intends to incorporate the EU GMP Annex 16 on batch release by a qualified person (QP) into a PIC/S guideline. The aim of PIC/S is for non-EU/EEA members to incorporate Annex 16 into their regulatory systems. The decision to incorporate Annex 16 is a result of the memorandum of understanding signed between the EMA and PIC/S following the revision of Annex 16 in 2016. The draft PIC/S Annex 16 is currently under consultation which is focussed on the non-EU/EEA members of PIC/S, however, the consultation is also open to the public until 15th September 2021.

http://bit.ly/RealCMC-3gLOXIf

New EMA Deferasirox product-specific bioequivalence guidance

The EMA has released a new product-specific bioequivalence guidance for Deferasirox, dispersible tablets (125 mg, 250 mg and 500 mg), film-coated tablets (90 mg, 180 mg, and 360 mg) and granules (90 mg, 180 mg and 360 mg). The guidance comes into effect on the 1st January 2022. An overview of the comments received during the public consultation stage of this new guidance has also been released.

http://bit.ly/RealCMC-3wxVM6Y

New USP harmonized chapter on visual inspections proposed

Pharmaceutical industry officials have proposed that the USP, together with input from the Ph. Eur. and Japanese Pharmacopoeia, develop a new harmonized chapter on visual inspections of parenteral drugs that would address current testing gaps. The proposed chapter would allow for more robust detection of visible particles in parenteral drugs, which is a common reason for recalls and warning letters in the US. The harmonised compendial chapter would include the use of ‘universally available standards’ to train inspectors, qualify the methods and validate results.

Further information on the recommendations may be viewed at the following link: https://bit.ly/RealCMC-3vg0y7F

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Last week’s round -up;
08-12 February 2021

UK MHRA is part of the Access Consortium along with the Australia Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic

The consortium is a medium-sized coalition of regulatory authorities that work together to promote greater regulatory collaboration and alignment of regulatory requirements. The original consortium, formed in 2007 and known as ‘ACSS’, comprised the national regulatory authorities of Australia, Canada, Singapore and Switzerland. In October 2020, the MHRA joined, and the group’s name was changed to ‘Access’. The consortium’s goal is to maximise international co-operation between partners in the consortium, reduce duplication, and increase each agency’s capacity to ensure patients have timely access to high quality, safe and effective therapeutic products. The Access consortium has developed 2 authorisation procedures: the New Active Substance Work Sharing Initiative and the Generic Medicines Work Sharing Initiative. The MHRA commenced work-sharing applications with Access partners from 1 January 2021. MHRA has just added the Expression of Interest (EOI) form for the New Active Substance Work Sharing Initiative to the MHRA website.

This EOI form and further details on the Access consortium are available at the following link: http://bit.ly/3d6sbud

UK MHRA updates Guidelines on UK Orphan Medicinal Products registration

Products with an orphan designation (OD) in the EU can be considered fora Great Britain (GB) orphan MA.  A UK-wide orphan MA can only be considered in the absence of an active EU OD.  There is no pre-authorisation OD in GB.  The MHRA has published a list of authorised orphan medicinal products registered by the UK at the following link: Orphan registered medicinal productsFor GB (England, Scotland and Wales), the MHRA offers incentives in the form of market exclusivity and full or partial refunds for MA fees to encourage the development of medicines in rare diseases. Waiver from Scientific Advice fees will also be available for UK-based SMEs.  On grant of a MA with orphan status, the product will benefit from up to 10 years of market exclusivity from similar products in the approved orphan indication.  The start of this market exclusivity period will be date of first approval of the product in GB.  Market exclusivity periods for Centrally authorised orphan medicine MAs that are converted to UK MAs will continue to apply.  Orphan medicines authorised in GB with the results of studies from a paediatric investigation plan (PIP) included in the product information are eligible for an additional 2 years of market exclusivity.

Further details are available at the following link: http://bit.ly/2N1KYMP

EMA product-specific bioequivalence guidance

The EMA has released the following product-specific bioequivalence guidance:

· Draft guidance for Deferasirox Dispersible Tablets, Film-coated Tablets and Granules, which is open for consultation until 31st March 2021.

· New guidance for Levothyroxine Tablets, effective from 1st July 2021.

· Revised guidance for Sorafenib 200 mg Film-coated Tablets.

http://bit.ly/RealCMC-3d6G5fS

Nitrosamines Updates

A new study has reported elevated levels of the potentially carcinogenic nitrosamine NDMA after the ingestion of ranitidine capsules across a range of physiologic conditions, with levels that greatly exceed FDA guidelines under some conditions. These results support the Agency’s request for all ranitidine products to be withdrawn from the market in April 2020. The EMA has released the following updates related to nitrosamine impurities: updated response templates, updated questions and answers guidance document and a new requirement to test medicinal products containing rifampicin for nitrosamines before releasing them to the market.

Further details on the ranitidine study and the EMA nitrosamine updates may be found at the following link: http://bit.ly/RealCMC-3aI3sd8

 

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Last week’s round -up;
30 November – 04 December 2020

Revised Palbociclib and Abiraterone product-specific bioequivalence guidance

The EMA has issued the following product-specific bioequivalence guidance: • A draft bioequivalence guidance for Palbociclib 75 mg, 100 mg and 125 mg hard capsules and 75 mg, 100 mg and 125 mg film-coated tablets. This guidance is open for public consultation until the 28th February 2021. • A newly adopted bioequivalence guidance for Abiraterone tablets 250 mg and 500 mg.

https://bit.ly/2UVpfae

Comments concerning revised texts published in Supplement 10.5

The EDQM has published the technical modifications that have been made to revised texts adopted by the European Pharmacopoeia Commission at the June 2020 session and published in Supplement 10.5. The details may also be consulted in the Knowledge database under ‘View history’.

https://bit.ly/RealCMC-2JGPzlk

UK medicines regulator gives approval for first UK COVID-19 vaccine

The first COVID-19 vaccine for the UK, developed by Pfizer/BioNTech, has today been given approval for use following a thorough review carried out by the Medicines and Healthcare products Regulatory Agency (MHRA). A copy of the press release is at the link: https://lnkd.in/dvDb4FR The BBC was reporting this morning that the UK is the first country worldwide to authorise a COVID-19 vaccine for a mass-vaccination programme.

https://lnkd.in/epySwje

Specific permits required to order Residual solvent solution class 1 CRS COVID-19 vaccine

As of the 1st January 2021, specific permits will be required to order R0250000 – Residual solvent solution class 1 CRS. This reference standard contains two controlled substances, carbon tetrachloride and 1,1,1–trichloroethane, which are ozone-depleting substances and, thus, prohibited in the EU except under certain conditions for laboratory and analytical uses. Users that require delivery within the EU, must provide a valid LabODS number to the EDQM when ordering the Ph. Eur. RS R0250000 reference standard, while any orders for delivery outside the EU are subject to licensing requirements.

Further information may be obtained from: https://bit.ly/RealCMC-3fVJT3i

Updated Brexit post transition guidance

The MHRA has updated its guidance on the location and other authorised personnel requirements for the post transition period. Guidance on centrally authorised MAs, mutual recognition and decentralised MAs, existing UK national MAs, GB MAs, named distributor, manufacturing sites, quality control and QPs was updated. The MHRA has also published a new section on the definition of products placed on to the GB market.

https://bit.ly/RealCMC-33rtSNg. 

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Last week’s round -up;
23 -27 November 2020

Updated Ph.Eur. vaccine package to support COVID-19 vaccine development

The EDQM has released an updated set of Ph.Eur. quality standards for vaccines to help support COVID-19 vaccine developers in designing appropriate analytical strategies for candidate vaccines and to ensure their quality and safety. The Ph.Eur. package now includes an additional 17 texts on analytical methods which are referenced in the recently released EDQM text on recombinant viral vectored vaccines for human use but may also be relevant for COVID-19 vaccines based on other technologies. The updated Ph. Eur. vaccines package is available for free from the EDQM website.

https://bit.ly/RealCMC-2V7cZ5X

New and revised FDA product-specific guidances

The FDA has released 13 new and 21 revised draft product-specific guidances, which are aimed at promoting generic competition by clarifying the agency’s expectations for bioequivalence studies. Eleven of the new and revised guidances concern complex products, such as metered dose inhalers or aerosol foams, and 24 of the guidances concern products without any approved generic competition.

https://bit.ly/RealCMC-2J8zaGd

CMDh updates – November 2020

The CMDh has updated the following guidance related to MRP, DCP and National Procedures: · Requirements on Submissions (number and format) for New Marketing Authorisation Applications within MRP, DCP and National Procedures (with tracked changes). · Requirements on submissions (number and format) for Variations and Renewals within MRP and National Procedures (with tracked changes).

https://bit.ly/RealCMC-399ZcDX

Revised Lapatinib product-specific bioequivalence guidance

The EMA has revised its draft product-specific bioequivalence guidance for Lapatinib 250 mg film-coated tablets. The draft guidance was significantly revised following feedback from the first public consultation, and it is open for a second public consultation until the 31st January 2021.

https://bit.ly/2ZOgRuu

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Last week’s round -up;
06 -13 November 2020

New EMA product-specific bioequivalence guidance

The EMA has released the following updated product-specific bioequivalence guidance: • A new draft guidance for Acenocoumarol 1 mg and 4 mg tablets. This draft guidance is open for public consultation until the 28th February 2021. • Revised guidance for Dasatinib 20, 50, 70, 80, 100 & 140 mg film-coated tablets and 10 mg/ml suspension, which comes into effect on the 1st May 2021. This product-specific bioequivalence guidance was updated to include the additional requirement for a fed study and the requirements for the suspension.

https://bit.ly/2UVpfae

Pharmeuropa 32.4 – Revised draft monographs for substances with a CEP

Twelve revised Ph. Eur. monographs for substances with a CEP have been published in Pharmeuropa 32.4. CEP holders are requested to consult the list of draft monographs and submit their comments on these draft monographs by the 31st December 2020. Users are also encouraged to review the draft monographs to ensure that their drug substances still comply with the revised drafts.

A list of the revised draft monographs may be viewed at the following link: http://bit.ly/RealCMC-3n9p0nE

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