Tuesday, 23 October 2018

FDA - Labeling for Biosimilar Products

FDA has issued a new guidance document ‘Labeling for Biosimilar Products’.

FDA - Labeling for Biosimilar Products. The goal of a biosimilar product development program is to demonstrate biosimilarity between the proposed product and the reference product — not to independently establish safety and effectiveness of the proposed product. A demonstration of biosimilarity means, among other things, that FDA has determined that there are no clinically meaningful differences between the proposed product and the reference product in terms of safety, purity, and potency.

The introduction to the report reads:

“This guidance is intended to help applicants develop draft labeling for proposed biosimilar products for submission in an application under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). The recommendations for prescription drug labeling in this guidance pertain only to the prescribing information (commonly referred to as the package insert), except for certain recommendations in section V pertaining to FDA-approved patient labeling (e.g., Patient Information, Medication Guide, and Instructions for Use).2 This guidance does not provide specific labeling recommendations for interchangeable products (see section VIII of this guidance). In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.”

See: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM493439.pdf

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Monday, 22 October 2018

Importance of Microbial Contamination Control

Tim Sandle has written an editorial of the special edition of the Journal of GxP Compliance, dedicated to pharmaceutical microbiology.

This special edition captures some of the current themes and issues relating to pharmaceutical microbiology and contamination control, and many of the points required to develop a control strategy.

The importance of microbiological control in relation to the manufacture of pharmaceutical and healthcare products is the theme of this special compilation for IVT Network. The articles selected highlight the twin themes of maintaining control through the assessment of risk and the use of sound, scientific methods to assess risk. This latter area includes the use of rapid and alternative methods.

While microbiology plays a role in drug development, through the application of biotechnology (including the development of anti-infective agents and with the manufacture of pharmaceutical products), a considerable part of the role of the pharmaceutical microbiologist is with protecting pharmaceutical and healthcare products from spoilage by microorganisms and thus protecting patients and consumers. With both sterile and non-sterile products, the effects can range from discoloration to the potential for fatality.

The reference is:

Sandle, T. (2018) Editorial: Importance of Microbial Contamination Control, SPECIAL EDITION: Essential Microbiology for GXP Compliance: 3-6 - http://www.ivtnetwork.com/article/essential-microbiology-gxp-compliance 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Sunday, 21 October 2018

Bacteria used as cell factories to produce biofuels

A new technique for manipulating small cell structures for use in a range of biotechnical applications including the production of biofuels and vaccines has been developed by a team of scientists led by the University of Kent.

The researchers did this by creating an improved system to allow for the synthesis of nano-reactors within cells that can be used to help convert sugar into fuel. The same technology can be used to coat nano-particles with proteins so that they can be used to generate vaccines.

The researchers redesigned and engineered the tiny bacterial cellular structures -- known as organelles -- so they can be more easily manipulated and deployed to turn bacteria into 'cell factories'.

The organelles, which are approximately 100 nm in diameter and known as bacterial microcompartments (BMCs), naturally house specific metabolic pathways, essentially a linked series of chemical reactions. Although BMCs have huge potential in the area of biotechnology, a key obstacle to their utilisation is the difficulty of targeting new pathways and processes into the BMC in a controllable fashion.

To address this problem, researchers at Kent's School of Biosciences redesigned a key surface component of the BMC that enables them to not only internalise proteins within the BMC but also display them on the surface of the organelle.

To achieve this the Kent researchers, working with others from University College London, the University of Bristol and Queen Mary University of London, utilised a pair of interacting peptides, developed at Bristol, to target proteins to these intracellular organelles. This technology facilitated the display of proteins on the surface of BMCs.

The use of synthetic biology then allowed the researchers to remodel one of the components of the BMC shell which in turn allowed them to use the same technology to internalise proteins within BMCs.


Matthew J. Lee, Judith Mantell, Ian R. Brown, Jordan M. Fletcher, Paul Verkade, Richard W. Pickersgill, Derek N. Woolfson, Stefanie Frank, Martin J. Warren. De novo targeting to the cytoplasmic and luminal side of bacterial microcompartments. Nature Communications, 2018; 9 (1) DOI: 10.1038/s41467-018-05922-x

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Saturday, 20 October 2018

Test detects disease-carrying mosquitoes, presence of biopesticide

A new diagnostic tool has been developed by researchers at The University of Texas at Austin that can easily, quickly and cheaply identify whether a mosquito belongs to the species that carries dangerous diseases such as Zika virus, dengue, chikungunya or yellow fever. It can also determine whether the bug has come into contact with a mosquito-control strategy known as Wolbachia.

"Many of these diseases are spreading in areas where they weren't common before," said Sanchita Bhadra, a research associate in the Department of Molecular Biosciences and first author on the paper. "Having surveillance is important in conjunction with any kind of outbreak, and this method allows a rapid test in the field."

The tool uses a smartphone camera, a small 3D-printed box and a simple chemical test to show whether a dead mosquito belongs to the Aedes aegypti species. Aedes aegypti carries Zika and other devastating viruses that afflict an estimated 100 million people worldwide each year. The species also is closely linked to the tripling of cases of mosquito-borne diseases in the United States since 2004.

The research appears in the journal PLOS Neglected Tropical Diseases.

The tool developed by scientists and students at UT Austin also detects the presence of a biopesticide called Wolbachia, a type of bacteria that keeps mosquitoes from spreading diseases. In countries around the world and in 20 U.S. states where the Aedes aegypti mosquito is found, scientists working in public health agencies have started to infect mosquitoes with Wolbachia by introducing the bacteria into a local mosquito population to help curb transmission of viruses.

Because mosquitoes show no outward signs of having the bacteria -- and because existing diagnostic tests are hard to read, expensive and logistically cumbersome -- the new tool represents a significant step forward for those hoping to monitor the effectiveness of Wolbachia.

"This test can happen without involving a lot of staff and equipment to make sure Wolbachia is effective and spreading as anticipated," Bhadra said.

Public health groups trap and kill mosquitoes routinely in conjunction with monitoring efforts, but existing technology requires a complex process to extract nucleic acid from inside mosquitoes, often after they have been dead for days and have started to decay, leading to greater expense and the possibility of more errors in lab tests than the new technology.

The new diagnostic tool uses a smartphone's camera and a simple test that can be done anywhere. It tests mosquitoes' nucleic acid without requiring a complicated process to remove it. Officially known as a loop-mediated isothermal amplification and oligonucleotide strand displacement, or LAMP OSD, the probe delivers a simple yes-or-no readout on a cellphone, with accuracy of greater than 97 percent.

In addition to the tests to detect mosquito species and Wolbachia, the team also is exploring use of the technology to easily identify whether trapped mosquitoes are carrying Zika, dengue and other pathogens.


Sanchita Bhadra, Timothy E. Riedel, Miguel A. Saldaña, Shivanand Hegde, Nicole Pederson, Grant L. Hughes, Andrew D. Ellington. Direct nucleic acid analysis of mosquitoes for high fidelity species identification and detection of Wolbachia using a cellphone. PLOS Neglected Tropical Diseases, 2018; 12 (8): e0006671 DOI: 10.1371/journal.pntd.0006671

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Friday, 19 October 2018

New compound effective against drug-resistant pathogens

Researchers from North Carolina State University have synthesized an analog of lipoxazolidinone A, a small molecule that is effective against drug-resistant bacteria such as MRSA. This molecule, a new synthetic compound inspired by a natural product, could be a useful chemical tool for studying other Gram-positive infections and may have implications for future drug creation.

Lipoxazolidinone A is a natural product which had been previously isolated from bacteria living in marine sediments. It is a secondary metabolite -- a small molecule produced by the bacteria that isn't key to its survival but is produced for a secondary purpose, like defense. When lipoxazolidinone A was initially isolated, researchers noted that it seemed effective against Gram-positive bacteria, like MRSA.

NC State chemist Joshua Pierce aimed to confirm those original findings and understand how the molecule's structure correlated to its function; in short, he wanted to recreate the molecule to see what portions were directly responsible for its anti-microbial properties and then potentially improve upon that structure.

Pierce, along with current NC State graduate student Kaylib Robinson and former students Jonathan Mills and Troy Zehnder, used novel chemical tools to synthesize lipoxazolidinone A in the lab. They were able to confirm that its chemical structure matched what the initial researchers had indicated, then they worked to identify the portion of the molecule that was responsible for the activity against Gram-positive bacteria. Their result was a compound with improved potency, JJM-35.

They tested JJM-35 against a panel of resistant and non-resistant bacteria. When tested against MRSA in-vitro, they found that the synthesized molecule was up to 50 times more effective than the natural product against several bacterial strains. Additionally, they found that the molecule was often more effective against resistant bacterial strains than it was against nonresistant strains.


Jonathan Mills, Kaylib Robinson, Troy Zehnder, Joshua G Pierce. Synthesis and Biological Evaluation of the Antimicrobial Natural Product Lipoxazolidinone AAngewandte Chemie International Edition, 2018; DOI: 10.1002/anie.201805078

Posted by Dr. Tim Sandle

Thursday, 18 October 2018

EU GMP Annex 2

Annex 2 to EU GMP has recently been updated. This is: “Annex 2 Manufacture of Biological active substances and Medicinal Products for Human Use.” This came into effect on 26th June 2018.

Annex 2 of the GMP Guide has been revised as a consequence of the adoption of the Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products pursuant to Article 5 of Regulation (EC) 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004.

Please note Annex 2 is no longer applicable to Advanced Therapy Medicinal Products to which applies the Commission guideline on Good Manufacturing Practice for Advanced Therapy Medicinal Products, published in Part IV of Eudralex Volume 4 and operational as of 22 May 2018.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Wednesday, 17 October 2018

SimpliciTB Clinical Trial Launched

TB Alliance has initiated a pivotal clinical trial, SimpliciTB (pronounced: sim-plis-i-tee-bee), that will evaluate whether a new four-drug regimen can treat most types of tuberculosis (TB) including multidrug-resistant TB (MDR-TB) more quickly and effectively than currently-available treatments. The first patients have been enrolled at the National Center for Tuberculosis and Lung Disease in Tbilisi, Georgia. SimpliciTB is expected to enroll 450 people with TB, including up to 150 with MDR-TB* across at least 26 centers in 10 countries in Africa, Asia, Europe and Latin America.

SimpliciTB will test the efficacy of a four-month treatment with the BPaMZ regimen, consisting of the drugs bedaquiline, pretomanid, moxifloxacin and pyrazinamide, in people with drug-sensitive TB. Outcomes will be compared against the standard six-month treatment regimen of isoniazid, rifampicin, pyrazinamide and ethambutol (HRZE), to determine whether BPaMZ may be able to shorten the duration of therapy for drug-sensitive TB by a third.

The trial will also assess BPaMZ’s potential to treat MDR-TB in six months. Currently, treatment for drug-resistant TB is extremely complicated, expensive, and lengthy, involving a wide variety of medicines that have debilitating side-effects, can include injectable drugs, and are administered for nine months to two years or longer. Today, people with MDR-TB often go untreated, and of those who do receive treatment only about half are cured.

“As resistance to current TB treatments continues to grow, we need to introduce all-oral drug regimens that can treat every person with TB in six months or less, regardless of their resistance profile,” said Mel Spigelman, president and CEO of TB Alliance. “If proven successful in SimpliciTB, the BPaMZ regimen would represent a major step toward this goal.”

The BPaMZ regimen was previously studied in the Phase 2b study called NC-005, in which people with MDR-TB who were treated with the BPaMZ regimen cleared TB bacteria from their lungs up to three times faster than drug-sensitive TB patients treated with the standard (HRZE) treatment. NC-005 was an eight-week trial conducted at 10 sites across Uganda, South Africa and Tanzania. SimpliciTB builds on these results, testing BPaMZ over a longer duration, in more people and across more sites, and against both drug-sensitive and MDR-TB.

According to the World Health Organization’s most recent Global Tuberculosis Report, there is growing resistance to available drugs, which means the disease is becoming more deadly and difficult to treat. WHO estimates that in 2016 there were 600,000 new cases with resistance to rifampicin–the most effective first-line drug—of which 490,000 had MDR-TB.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Tuesday, 16 October 2018

Antimicrobial stewardship in veterinary settings

Antimicrobial resistance is a global public health challenge. Antimicrobial drugs have been widely used in human and veterinary medicine for more than 60 years. When used judiciously, antimicrobials can effectively fight bacterial infections. However, we know that overuse or misuse of these drugs promotes the development of antimicrobial-resistant bacteria.

A statement from FDA Commissioner Scott Gottlieb.

For all of these reasons, it’s critical that we implement good antimicrobial stewardship practices in human healthcare and veterinary settings. We must continue to take new steps to slow the development of resistance and extend the usefulness of these lifesaving drugs.

Combating antimicrobial resistance continues to be a top priority for the U.S. Food and Drug Administration (FDA).

To further these efforts, the FDA will soon implement a new, five-year blueprint for how the FDA plans to build on its current programs to advance antimicrobial stewardship in veterinary settings. We’ll expand on the FDA’s existing actions, and launch some new programs. Our aim is to reduce overuse of antimicrobial drugs and combat the rising threat of resistance.

As part of the FDA’s regulatory mission, our Center for Veterinary Medicine (CVM) is responsible for ensuring the safety and effectiveness of animal drugs, including antimicrobials. CVM has already taken important steps to update the approved conditions of use for medically important antimicrobials (i.e., antimicrobials important for treating human disease) to support judicious use in food-producing animals. While important progress has been made, we know that additional work is needed to address the complex challenge of antimicrobial resistance.

See: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm615245.htm

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Monday, 15 October 2018

Use of Hazard Analysis and Critical Control Points (HACCP) - Part 1: Assessing Microbiological Risks

Environmental monitoring is an important part of a biocontamination control strategy in a pharmaceutical or healthcare organization. Monitoring is undertaken in order to assess if controlled areas are operating as designed and to assess the risk of microorganisms to pharmaceutical products, in terms of contamination transfer. Monitoring data is assessed against assigned limits (or frequencies) and by assessing the collected data over time in the form of trend analysis. Importantly, environmental monitoring is used to confirm that sufficient controls are in place; in itself it cannot be used as a substitute for control.

There are several aspects to environmental monitoring and each aspect must be described in an environmental monitoring program; such elements include method selection, determining frequencies of monitoring, locations for sampling, selection of culture media, choice of data analysis tools and so on. This article looks at one of these aspects: determining the locations for monitoring and here a risk assessment tool can be applied for this purpose: Hazard Analysis and Critical Control Point (HACCP).

For pharmaceuticals and healthcare there are a myriad of different risk assessment tools available, some of which are of more use than others (and of these more useful approaches, some are easier to understand and implement). The foremost risk assessment tool in pharmaceuticals appears to be Failure Modes and Effects Analysis (FMEA). While FMEA has many uses, especially for deconstructing equipment to try and to detect points of failure (‘failure modes’) it is perhaps less suited for following a process flow. This is where HACCP has its advantages. Unlike FMEA, which uses risk scoring based on an ordinal number concept, HACCP is a qualitative risk assessment tool.

HACCP is a risk assessment approach, originating in the food industry that can be used to assess physical, chemical, and biological hazards. HACCP is designed in such as way so that the potential hazards, or points of potential failure (or in the case of environmental monitoring – contamination) that can occur are identified. Hence HACCP is a pro-active tool, consisting of a preventive approach to identify hazards throughout a process.

The locations where potential hazards can occur are, within the HACCP lexicography, known as Critical Control Points (CCPs). At these identified points actions can be taken to reduce or eliminate the risk of the hazards being realized. HACCP involves focusing on where the most important control points in a process are and, where risks remain, undertaking monitoring. Once these monitoring locations are established critical limits are to be set. The monitoring to critical limits enables the process to be verified as being in control (or not). The output is a documented plan to control these scenarios.

This article discusses the concept of risk and the basis of HACCP. A follow up article (part B) looks at an example of environmental monitoring location determination using HACCP methodology.

The reference is:

Sandle, T. (2018) Useof Hazard Analysis and Critical Control Points (HACCP) - Part 1: AssessingMicrobiological Risks, Journal of GxP Compliance, 22 (4): 1-12

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Free webinar - Cleaning Validation Top Challenges: What you need to know. This two-part Webinar presents three of the top issues that companies face today. In the first part, Dr. Tim Sandle challenges us to evaluate our sampling plan for assessing microbiological levels of contamination and discusses how to reduce this type of risk in the process. In the second part, Ms. Endisch introduces the idea of automation and data integrity, as the cleaning validation process is largely manual in the majority of organizations, and how this can help to provide a more scientific and justifiable process. She answers the question ‘how to do more with the resources I have’ in relation to calculating MAC (maximum allowable carry-over) levels and evaluating the worst case product, see: https://register.gotowebinar.com/register/4825207172373924610

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Sunday, 14 October 2018

MSF - New Medical Approaches as Ebola Continues to Spread

As the Ebola outbreak in the northeast of the Democratic Republic of Congo (DRC) continues to spread, the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) has begun using novel medical approaches to prevent new infections and improve survival chances for those infected.

MSF launched its intervention, within the response plan of the Congolese Ministry of Health (MoH), soon after the outbreak was registered in Mangina, a small town to the northwest of Beni Province, in early August. In addition to the traditional “six pillars” of Ebola response—including caring for those who are sick, carrying out health promotion activities, and conducting infection prevention and control activities—MSF is using more innovative approaches and new tools to best meet the needs of patients. For example, MSF has started testing blood samples of suspect cases in laboratories within the Ebola Treatment Centers (ETCs) themselves rather than in an outside lab, which allows the teams to react faster to changing medical conditions of patients.

“While the number of confirmed Ebola cases is not skyrocketing, the situation remains worrying,” said Laurence Sailly, MSF emergency coordinator. “There are confirmed patients in big cities like Beni and Butembo, but also in places far away from the epicenter, close to the Ugandan border. That makes it difficult to contain the epidemic. Like all Ebola outbreaks, it’s difficult to predict how it may evolve, but we are ready to react and support the ministry of Health whenever new cases appear.”

To date, 181 cases have been reported—of which 146 have been confirmed by laboratory tests—80 people have died, and 50 have recovered.

MSF is currently working with the MoH in ETCs in Mangina, Butembo, and Tchomia, close to the Ugandan border.

For the first time during an Ebola outbreak, five developmental drugs are being used to treat people. The presence of on-site testing capability means people who test positive for the virus are offered these new treatments within 24 hours of their confirmation. Mortality among those infected is very high, at roughly 50 percent, so administering the new drugs quickly may have the potential to increase the chance of survival.

“It’s very positive to have a treatment that seems promising, even if there is currently no scientific evidence that any of these drugs work for people with Ebola,” said MSF doctor and Ebola expert, Hilde De Clerk. “But it’s a good step forward. We can offer Ebola patients access to potentially lifesaving drugs while preparing for a clinical trial implementation that will hopefully determine efficacy and safety.”

The outbreak has occurred in a densely populated area of DRC, marked by conflict and regular population movements, making it difficult to identify and track active chains of transmission and trace contacts of those infected with Ebola.

“A potential key to successfully control the outbreak is to react fast,” said Sailly. “Whenever a confirmed Ebola case is found, a small, multidisciplinary rapid response team (nurse, epidemiologist, logistician, health promoter, medical doctor) is sent as fast as possible to work on this new hotspot and prepare for a potential bigger intervention.” MSF sent such teams to Luotu and Tchomia immediately after a confirmed Ebola patient was detected in those areas.

Immunization activities with the Ebola vaccine (rVSVDG-ZEBOV) quickly followed the declaration of the epidemic as the WHO and MoH began providing the vaccine to people who had contact with someone with Ebola. Soon after, MSF began offering vaccinations to frontline health workers, people involved in burials, and religious figures, who run a higher risk of becoming infected. So far, 13,750 people have been vaccinated.

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Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Saturday, 13 October 2018

Proposed EU Guidelines to GMP Annex 1

Madhu Raju Saghee and Tim Sandle have written a review article about the sterility assurance changes expected from forthcoming update to EU GMP Annex 1. The abstract reads:

"To assist enhancement of sterility assurance programmes, this article highlights the main changes in the new draft Annex 1. In developing the draft, the European Medicines Agency made considerable efforts to integrate new concepts and facilitate the introduction and implementation of innovative technologies. To be proactive, it is advised that existing sterility assurance programmes be assessed against the changes to provide a gap assessment to understand the actions and resources required to align with the proposed new guidance."

The reference is:

Saghee, M. and Sandle, T. (2018) Proposed EU Guidelines to GMP Annex 1: main changes that trigger enhancements to your sterility assurance programme, GMP Review, 17 (1): 4-8

See: GMP Review

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Friday, 12 October 2018

New Method for Screening Polymeric Antimicrobials

Researchers at the University of Warwick have developed a method to synthesize large libraries of polymers to make their screening for antimicrobial activity faster and without the need to use sealed vials, the University announced in an Aug. 14, 2018 press release. The researchers are investigating innovative antimicrobials to address antimicrobial resistance.

The polymers were synthesized using a high-throughput technique with liquid-handling robots and photochemical polymerization. “Whilst many people have successfully mimicked antimicrobial peptides with polymers, the limiting step was the number of different combinations of building blocks you can use. We used simple robotics and a light controlled polymerization, which lets us do the chemistry open to air, without any sealed vials, which are essential for most polymer syntheses,” Professor Matthew Gibson from Warwick’s Department of Chemistry and Warwick Medical School and lead author of a paper published in Chemistry; A European Journal, said in the press release.

“We prepared the polymers in such a way that at the end of the reaction, we use the robotics to mix polymers directly with bacteria, so we could look for unexpected activity, which we achieved,” explained Sarah-Jane Richards, from the Gibson Group at the University of Warwick and the lead author of the work, in the press release. While traditional antimicrobials, such as penicillin, work by inhibiting key cellular processes, the Warwick team is investigating host-defense peptides, which are broad spectrum antimicrobials that function by breaking apart the membrane of bacteria. “Surprisingly, the best materials do not seem to break apart the bacteria as we predicted, but rather inhibit their growth. We are investigating this further," added Richards.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Thursday, 11 October 2018

Generic versions of epi-pens approved

FDA announced on August 16, 2018 that it has given approval to Teva Pharmaceuticals’ generic version of EpiPen and EpiPen Jr. (epinephrine) auto-injector in 0.3 mg and 0.15 mg strengths for the emergency treatment of allergic reactions, including anaphylaxis. While the agency has approved other epinephrine auto-injectors before, this is the first authorized direct competitor to Mylan’s EpiPen.

The epinephrine auto injector is a combination product, consisting of a drug and a device, that automatically injects a dose of epinephrine into a person’s thigh to stop an allergic reaction. The development of generic versions of combination products, such as EpiPen, has been challenging, according to FDA, because of their complex nature.

“Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the US is part of our longstanding commitment to advance access to lower cost, safe, and effective generic alternatives once patents and other exclusivities no longer prevent approval,” said FDA Commissioner Scott Gottlieb, M.D. “This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages. The path to developing generic drug-device combination products like this one is challenging.”

See: https://www.pharmtech.com/first-generic-version-epipen-gets-approval-0

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Wednesday, 10 October 2018

Process Licensing Office joins MHRA

The Process Licensing Office has today joined the Inspectorate to become the Inspectorate & Process Licensing Group.

The Process Licensing Office are responsible for: 
  • Processing Initial and Variation Applications for Wholesale Distribution Authorisations, Broker Registrations and Manufacturing Licences.
  • Processing Registration applications, variations and annual reports for Manufacturers, Importers and Distributors of active substances.
  • Issuing Licences
  • Issuing and Re-Issuing GMP/GDP/GLP Certificates.
  • Issuing Export Certificates for Pharmaceutical companies who wish to export products from the UK to another market.  These Certificates are issued under the World Health Organisation (WHO) Certificate scheme.
  • Answering Freedom of Information (FoI) requests on behalf of IE&S.
This change forms part of the ongoing Transformation programme at MHRA and is effective from 1st August 2018. See:  https://mhrainspectorate.blog.gov.uk/2018/08/01/process-licensing-office-joins-the-inspectorate/

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Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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